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

FDA device recall Z-1660-2013 · posted 2013-07-03 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

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.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

LRO

Quantity affected

134 trays

Distribution

U.S. Military Hospital on base in Landstuhl, Germany

Date initiated

2012-11-21

Date posted

2013-07-03

Date terminated

2013-07-12

Location

Chester, VA