Z-0663-2013Class II

Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a...

Name: Z-0663-2013 Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a...
Creator: Merit Medical Systems, Inc.
Published: 2012-09-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2012-09-14 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices... on 2012-09-14. FDA classified it as Class II and gives the reason as "Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0663-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Posted: 2013-01-10
Terminated: 2013-01-14
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the
FDA root cause: Under Investigation by firm
Action: Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" dated September 14, 2012 to all affected customers. The letter identified the affected product, description of problem and recommended user actions to be taken. Consignees were requested to ensure that all appropriate personnel are notified of the affected Merit trays so that they can take immediate action. They were instructed to quarantine all affected kits, remove the bag of 0.9% Sodium Chloride and return the affected product to Merit for credit or replacement. Consignees were requested to complete and sign the Customer Response Form and immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031 and mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Consignees were given product return instructions.
Quantity in commerce: 422 total kits/trays
Distribution: Distributed in Mississippi and New Jersey.
Product codes and lots: Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0663-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0663-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-10

Product code NGT

K090882Class IIFlush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. / cleared 2010-04-23

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 2026-09-06. View this recall on fda.gov (opens on fda.gov)