Recall Z-0981-2017 ยท KMK Device, Intravascular Catheter Securement
Bard Access Systems
StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock C
| Date | Jan 10, 2017 (initiated Dec 9, 2016) |
| Status | Terminated |
| Reason | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.). |
| Root cause | Process design |
| Action | Bard sent an Urgent Customer Notification letter dated December 12, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and identify any product subject to the notification. Please direct any return requests and/or questions to Shelly Gilbert at 1-800-290-1689. |
| Quantity | 30,000 units total |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.