Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice P
FDA device recall Z-0413-2010 · posted 2009-11-23 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Surgical gloves in hospital convenience kits may be degraded and tear during use.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KDD
- Quantity affected
- 378 units
- Distribution
- USA distribution: nine hospitals in Texas and Colorado.
- Date initiated
- 2009-05-19
- Date posted
- 2009-11-23
- Date terminated
- 2009-12-03
- Location
- Chester, VA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984558) | Ansell Perry | 1999-02-26 |