Cadd
75 catalogue numbers from 21-7395-24, listed by ICU Medical, Inc, United States, under Set, Administration, Intravascular. 49 manufacturers in China are registered for this product code.
49manufacturers in China registered for this device type
75catalogue numbers in this listing
27510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K040636 |
| Record published | 2016-11-16 |
| Record revised | 2025-04-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 12, box of 15, box of 50, case of 15, carton of 12, carton of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21-7395-24 | In distribution | |
| 21-7363-24 | In distribution | |
| 21-7105-24 | In distribution | |
| 21-7107-24 | In distribution | |
| 21-7060-24 | In distribution | |
| 21-7071-24 | In distribution | |
| 21-7062-24 | In distribution | |
| 21-7022-24 | In distribution | |
| 21-7046-24 | In distribution | |
| 21-7108-24 | In distribution | |
| 21-1200-24 | In distribution | |
| 21-7301-24 | In distribution | |
| 21-7115-24 | In distribution | |
| 21-7302-24 | In distribution | |
| 21-7083-24 | In distribution | |
| 21-7384-24 | In distribution | |
| 21-7109-24 | In distribution | |
| 21-7095-24 | In distribution | |
| 21-7375-24 | In distribution | |
| 21-7034-24 | In distribution | |
| 21-7039-24 | In distribution | |
| 21-7091-24 | In distribution | |
| 21-7036-01 | In distribution | |
| 21-7075V-01 | In distribution | |
| 21-7336-24 | In distribution | |
| 21-7094-24 | In distribution | |
| 21-7310-24 | In distribution | |
| 21-7323-24 | In distribution | |
| 21-7044-24 | In distribution | |
| 21-7365-24 | In distribution | |
| 21-7322-24 | In distribution | |
| 21-7383-24 | In distribution | |
| 21-7092-24 | In distribution | |
| 21-7386-24 | In distribution | |
| 21-7333-24 | In distribution | |
| 21-7364-24 | In distribution | |
| 21-7345-24 | In distribution | |
| 21-7045-24 | In distribution | |
| 21-7324-24 | In distribution | |
| 21-7390-24 | In distribution | |
| 21-7339-24 | In distribution | |
| 21-7040-24 | In distribution | |
| 21-7359-24 | In distribution | |
| 21-7388-02 | In distribution | |
| 21-7346-24 | In distribution | |
| 21-7023-24 | In distribution | |
| 21-7308-24 | In distribution | |
| 21-7052-24 | In distribution | |
| 21-7391-24 | In distribution | |
| 21-2112-0402-249 | In distribution | |
| 21-7106-24 | In distribution | |
| 21-7147-24 | In distribution | |
| 21-7349-24 | In distribution | |
| 21-7047-24 | In distribution | |
| 21-7361-24 | In distribution | |
| 21-7399-01 | In distribution | |
| 21-2131-01 | In distribution | |
| 21-7024-24 | In distribution | |
| 21-7061-24 | In distribution | |
| 21-7300-24 | In distribution | |
| 21-7090-24 | In distribution | |
| 21-7385-24 | In distribution | |
| 21-7081V-01 | In distribution | |
| 21-7355-24 | In distribution | |
| 21-7381-24 | In distribution | |
| 21-7059-24 | In distribution | |
| 21-7321-24 | In distribution | |
| 21-7394-24 | In distribution | |
| 21-7309-24 | In distribution | |
| 21-7389-24 | In distribution | |
| 21-7081-24 | In distribution | |
| 21-7021-24 | In distribution | |
| 21-7343-24 | In distribution | |
| 21-7089-24 | In distribution | |
| 21-7357-24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250616 | 2025-06-05 |
| K151969 | 2016-01-19 |
| K100576 | 2010-12-17 |
| K100434 | 2010-07-09 |
| K090189 | 2009-04-10 |
| K082806 | 2009-04-06 |
| K081361 | 2008-08-28 |
| K070532 | 2007-03-20 |
| K053106 | 2006-01-10 |
| K051437 | 2005-08-03 |
| K042182 | 2004-09-01 |
| K040710 | 2004-08-11 |
| K041410 | 2004-07-28 |
| K033290 | 2004-04-12 |
| K021692 | 2003-12-04 |
| K003513 | 2001-01-11 |
| K000472 | 2000-05-10 |
| K974589 | 1998-01-09 |
| K973167 | 1997-11-17 |
| K972712 | 1997-10-01 |
| K970855 | 1997-06-24 |
| K954813 | 1995-11-29 |
| K941190 | 1995-01-31 |
| K940296 | 1994-02-22 |
| K915571 | 1992-09-21 |
| K910546 | 1991-04-29 |
| K840273 | 1984-03-06 |
Recalls Naming This Product
62 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2025-08-06 | Class II | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. | 29811 units | |
| ICU Medical, Inc | UDI-DI | 2025-08-06 | Class II | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. | 289098 units | |
| ICU Medical, Inc | UDI-DI | 2025-08-06 | Class II | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. | 211750 units | |
| ICU Medical, Inc | UDI-DI | 2025-08-06 | Class II | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. | 987911 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-04-10 | Class I | Software design | Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. | US: 83,833 items ; OUS: 71,843 items | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-04-10 | Class I | Labeling design | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. | 185,975 US; 127,701 OUS Total | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-04-10 | Class I | Under Investigation by firm | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | 313,676 total units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 125928 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 385558 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 26160 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 119535 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 41964 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 109563 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 8976 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 2881080 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage. | 120960 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-06-26 | Class II | Device Design | The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug. | 156,400 AC adapters | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-02-27 | Class I | Software Manufacturing/Software Deployment | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: ” For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2022-12-09 | Class I | Under Investigation by firm | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False “No Disposable Attached (NDA)” Alarms | 1616714 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2022-12-09 | Class I | Under Investigation by firm | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False “No Disposable Attached (NDA)” Alarms | 45285351 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2022-12-09 | Class I | Under Investigation by firm | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False “No Disposable Attached (NDA)” Alarms | 726,878 units | |
| Smiths Medical Asd, Inc. | UDI-DI | 2022-12-09 | Class I | Under Investigation by firm | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False “No Disposable Attached (NDA)” Alarms | 47595495 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-07-14 | Class II | Process control | Product may have been manufactured with an air filter assembled in an incorrect orientation. | 371 units | 2023-08-04 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-05-15 | Class II | Process control | One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24. | 7,035 | 2018-04-04 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-03-17 | Class II | Packaging process control | Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text d | 38,415 (38145 US; 2268 OUS) | 2019-07-03 |
| Smiths Medical Asd, Inc. | 510(k) number | 2016-12-09 | Class II | Unknown/Undetermined by firm | The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada. | 641,070 units | 2017-12-14 |
| Smiths Medical Asd, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop. | 13,696,830 units | 2017-12-13 |
| Smiths Medical Asd, Inc. | 510(k) number | 2015-02-02 | Class II | Under Investigation by firm | Smiths Medical has become aware of an issue with specific lots of 50mL CADD” Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports | 48,208 (17,040 US, 31,168 OUS). | 2016-03-18 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-12-09 | Not classified | Mixed-up of materials/components | Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. EXPANDED: Smiths Medical became aware that an additional Pr | 5,385 EXPANDED 16,125 devices | 2012-11-06 |
| Smiths Medical MD, Inc. | 510(k) number | 2007-12-14 | Not classified | Process control | Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps | 4,644 | 2011-01-11 |
| Smiths Medical MD, Inc. | 510(k) number | 2005-12-08 | Not classified | Other | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. | 2 boxes of 40 Admin. Sets (80 sets in total) | 2007-01-05 |
| Smiths Medical MD, Inc. | 510(k) number | 2005-12-08 | Not classified | Other | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. | 4 boxes of 40 Admin. Sets (160 sets in total) | 2007-01-05 |
| Smiths Medical MD, Inc. | 510(k) number | 2005-12-08 | Not classified | Other | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. | 7 boxes of 30 Admin. Sets (210 sets in total) | 2007-01-05 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 4,760 units (119 cases) Each case contains 40 units. | 2006-06-25 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 23,960 units (599 cases) Each case contains 40 units. | 2006-06-25 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 31,320 units total: 6,150 units (205 cases) to Japan, 17,970 | 2006-06-25 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 28,800 units total: 10,800 units (360 cases) Internationally | 2006-06-25 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 6,690 units total: 3,600 units (120 cases) Internationally & | 2006-06-25 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 840 units (28 cases) within USA Each contain 30 units. | 2006-06-25 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-12-03 | Not classified | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask | 3,600 units (120 cases) within USA. Each contain 30 unit. | 2006-06-25 |
Showing 40 of 62.
Recalls
33 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and | 163,500,199 | |
| 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and | 100,712,657 | |
| 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, | 107,800 | |
| 2025-12-19 | Class II | Process control | Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leak | 14,684,607 items | |
| 2025-08-06 | Class II | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. | 265500 units | |
| 2025-08-06 | Class II | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. | 15546 units | |
| 2022-08-01 | Class II | Process control | Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. | Total of all affected units = 5,795,989 units | |
| 2022-08-01 | Class II | Process control | Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. | Total of all affected units = 5,795,989 units | |
| 2022-08-01 | Class II | Process control | Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. | Total of all affected units = 5,795,989 units | |
| 2022-08-01 | Class II | Process control | Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. | Total of all affected units = 5,795,989 units | |
| 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | ||
| 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | ||
| 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | ||
| 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | ||
| 2021-03-16 | Class II | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. | ||
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 19850 | |
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 1856578 | |
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 217522 | |
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 33900 | |
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 37000 | |
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 55000 | |
| 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 325 | |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
| 2020-07-06 | Class II | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Total of all products (Listed #1 thru 101) = 304735 units | 2023-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.