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.
This recall has been terminated (originally issued November 23, 2009).
- Company
- Merit Medical Systems, Inc.
- Recall Initiated
- May 19, 2009
- Posted
- November 23, 2009
- Terminated
- December 3, 2009
- Recall Number
- Z-0413-2010
- Quantity
- 378 units
- Firm Location
- Chester, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Surgical gloves in hospital convenience kits may be degraded and tear during use.
Distribution
USA distribution: nine hospitals in Texas and Colorado.
Lot / Code Info
Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04
Root Cause
Nonconforming Material/Component
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.