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 Recall Z-0413-2010 · Posted 2009-11-23
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeKDD
Date Initiated2009-05-19
Date Terminated2009-12-03
Product Quantity378 units
Reason for Recall
Surgical gloves in hospital convenience kits may be degraded and tear during use.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA distribution: nine hospitals in Texas and Colorado.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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