Z-1660-2013Class II

Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally...

Name: Z-1660-2013 Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally...
Creator: Merit Medical Systems, Inc.
Published: 2012-11-21
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2012-11-21 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for... on 2012-11-21. FDA classified it as Class II and gives the reason as "Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1660-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-21
Posted: 2013-07-03
Terminated: 2013-07-12
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray 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. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
Product code: LRO General Surgery Tray
Reason for recall: Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Root cause tag: packaging
FDA root cause: Packaging
Action: Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" letter dated November 21, 2012, to affected customer. The letter identified the product, the problem, and the action to be taken by the customer: Ensure all personnel within their institution to which the affected Merit trays were distributed are notified, quarantine all affected trays and return the affected product to Merit - Maastricht. Complete and sign the Customer Response Form attached to this letter and perform the following steps:(1) Immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031. (2) Mail the completed original Customer Response Form from (1) above using the provided postage-paid, self-addressed envelope to Merit. Product Return Instructions: Please return the affected products by shipping them back to Merit via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department, RGA #NC-54948 Merit Medical Maastricht, Amerikalaan 42, 6199 AE Maastricht - Airport, The Netherlands. NOTE: A copy of the Customer Response Form must accompany the shipment. If you have any questions, please call 1-804-416-1048.
Quantity in commerce: 134 trays
Distribution: U.S. Military Hospital on base in Landstuhl, Germany
Product codes and lots: Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1660-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1660-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-03

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)