Recall Z-0413-2010 ยท KDD Kit, Surgical Instrument, Disposable
Merit Medical Systems, Inc.
Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.
| Date | Nov 23, 2009 (initiated May 19, 2009) |
| Status | Terminated |
| Reason | Surgical gloves in hospital convenience kits may be degraded and tear during use. |
| Root cause | Nonconforming Material/Component |
| Action | Merit Medical Systems notified customers by phone, fax, or visit by sales representatives on 05/19/09. The notification advised of the convenience kit correction due to the recall of the Derma Prene Ultra Surgical Gloves, and that use of the product should cease immediately. Sales representatives were instructed to provide replacement gloves and "warning" stickers to be placed on identified kits in inventory. The warning stickers advise the customer to discard the surgical gloves in the kit and replace. Customers were requested to verify product disposition by signing a response form. |
| Quantity | 378 units |
| Distribution | USA distribution: nine hospitals in Texas and Colorado. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Perry, Feb 26, 1999 |