—#86098

Product

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.

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K984558
Affected lot / code info: Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04

Why it was recalled

Surgical gloves in hospital convenience kits may be degraded and tear during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 12701 N. Kingston Avenue, Chester, Virginia 23836-2700

Distribution

Distribution pattern: USA distribution: nine hospitals in Texas and Colorado.

Timeline

Recall initiated: 2009-05-19
Posted by FDA: 2009-11-23
Terminated: 2009-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86098. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.