Recall Z-1443-2015 ยท GDZ Handle, Scalpel
Bard Access Systems
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
| Date | Apr 14, 2015 (initiated Jun 24, 2014) |
| Status | Terminated |
| Reason | Potential for inadvertent scalpel stick injury involving the safety scalpel. |
| Root cause | Component change control |
| Action | Bard sent an Urgent Notification letter date June 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed on the proper device use and safety mechanism activation of the Safe-Cut Safety Scalpel. For questions call coordinator, Shelly Gilbert, at 1-800-290-1689. |
| Quantity | 51,025 units |
| 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.