Recall Z-2120-2017 ยท KMK Device, Intravascular Catheter Securement
Bard Access Systems Inc.
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.
| Date | May 19, 2017 (initiated Apr 25, 2017) |
| Status | Terminated |
| Reason | StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. |
| Root cause | Process control |
| Action | Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them |
| Quantity | 4,500 units |
| Distribution | Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.