PharmGuard
Catalogue number 2193, 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
1catalogue number
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) | K170982 |
| Record published | 2017-09-21 |
| Record revised | 2025-04-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2193 | 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
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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 | 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 | 45285351 units |
Recalls
37 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. | 289098 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. | 29811 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. | 987911 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. | 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. | 211750 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.