Recall Z-0980-2014— Merit Medical Systems, Inc.

Class I FDA medical device recall by Merit Medical Systems, Inc., initiated 2013-09-30, terminated 2014-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit 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. Custom procedural trays 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.. Reason: Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodged through the tissue and could possibly cause a pneumothorax or hemothorax..

Recalling firm

Merit Medical Systems, Inc.

Classification

Class I

Status

Terminated

Initiated

2013-09-30

Terminated

2014-05-13

Firm location

Chester, VA, United States

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