Recall Z-2120-2017— Bard Access Systems Inc.
Class II · Terminated
Class II FDA medical device recall by Bard Access Systems Inc., initiated 2017-04-25, terminated 2017-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.. Reason: StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip..
- Recalling firm
- Bard Access Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-25
- Terminated
- 2017-08-21
- Firm location
- Salt Lake City, UT, United States
Product description
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
Reason for recall
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Data sourced from openFDA. This site is unofficial and independent of the FDA.