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.
Recall
- Recall Number
- Z-1660-2013
- Event Number
- 64078
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 3002975287
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- November 21, 2012
- Posted
- July 3, 2013
- Terminated
- July 12, 2013
- Address
- 12701 N Kingston Ave, Chester, VA, 23836-2700
Description
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.
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.
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.
U.S. Military Hospital on base in Landstuhl, Germany
134 trays