Recall Z-1660-2013— Merit Medical Systems, Inc.

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2012-11-21, terminated 2013-07-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Merit Medical Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-11-21

Terminated

2013-07-12

Firm location

Chester, VA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.