Z-0413-2010

Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1)...

Name: Z-0413-2010 Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1)...
Creator: Merit Medical Systems, Inc.
Published: 2009-05-19
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2009-05-19 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2)... on 2009-05-19. The reason FDA records is "Surgical gloves in hospital convenience kits may be degraded and tear during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0413-2010
Status: Terminated
Initiated: 2009-05-19
Posted: 2009-11-23
Terminated: 2009-12-03
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Surgical gloves in hospital convenience kits may be degraded and tear during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 378 units
Distribution: USA distribution: nine hospitals in Texas and Colorado.
Product codes and lots: Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04

Product code KDD

K984558Class IDerma Prene Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)Ansell Perry / cleared 1999-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)