VersaSafe
VersaSafe Locking Blunt Cannula 11 Gauge
49manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
23recalls 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 | CareFusion 303, Inc, United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-22 |
| Record revised | 2020-04-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 125 °F |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9391-0300 | 20 | 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 |
|---|---|
| K171957 | 2017-07-19 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2025-09-11 | Class I | Under Investigation by firm | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. | ||
| 2018-04-20 | Class II | Process control | Complaints where users were unable to prime the administration set. | 118,254,342 | 2021-02-10 |
| 2017-11-06 | Class II | Under Investigation by firm | Reports of incorrect priming volume due to manufacturing with incorrect tubing. | 25,400 units | 2020-12-07 |
| 2017-06-30 | Class II | Packaging process control | Punctures in blister packaging that was detected during the packaging process. | 1,546,800 units | 2021-02-03 |
| 2017-02-20 | Class II | Process control | CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing. | 1,200 units | 2017-11-17 |
| 2017-02-20 | Class II | Under Investigation by firm | CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter. | 12,850 units | 2018-10-29 |
| 2016-11-17 | Class II | Other | CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposu | 384,923 units | 2018-10-29 |
| 2016-02-15 | Class II | Other | CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set. | 5,760 units | 2016-10-24 |
| 2015-11-05 | Class II | Other | CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. | 1,445,180 units | 2017-03-01 |
| 2015-10-09 | Class II | Process control | CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. | 21,000 units | 2017-03-02 |
| 2015-01-13 | Class II | Under Investigation by firm | CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. | 7,440 units | 2016-03-15 |
| 2014-06-17 | Class II | Labeling Change Control | CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it | 5,600 units | 2016-09-20 |
| 2014-03-19 | Class II | Nonconforming Material/Component | Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. | 7,700 units | 2015-06-06 |
| 2014-01-22 | Class II | Under Investigation by firm | CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a fe | 3,500,000 units (2,136,200 units in US; 1,404,700 units fore | 2015-08-06 |
| 2014-01-16 | Class II | Nonconforming Material/Component | CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak. | 9,550 units | 2014-08-06 |
| 2013-11-08 | Class II | Employee error | CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended. | 3500 units | 2014-04-17 |
| 2013-11-08 | Class II | Employee error | CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing. | 480 units | 2014-05-27 |
| 2013-08-30 | Class II | Process design | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. | 15860 units | 2014-04-16 |
| 2013-08-30 | Class II | Employee error | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (cl | 600 units | 2013-10-28 |
| 2013-08-30 | Class II | Employee error | CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years. | 2,850 units | 2013-12-26 |
| 2012-12-20 | Class II | Nonconforming Material/Component | CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing. The separation may be observed at priming or observed during use. If a separation between t | 5,050 units | 2013-07-25 |
| 2011-04-20 | Not classified | Device Design | Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component. | 26,150 units | 2011-11-28 |
| 2007-08-30 | Not classified | Finished device change control | Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or o | 76, 300 units | 2012-03-28 |
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.