Recall Z-0980-2014 ยท NGT Saline, Vascular Access Flush
Merit Medical Systems, Inc.
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 devic
| Date | Feb 20, 2014 (initiated Sep 30, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Merit Medical sent via FedEx an "URGENT PRODUCT RECALL NOTICE" dated September 30, 2013 to all affected customers. The letter identified the affected product, description of problem and recommended user actions to be taken. Consignees were given two options: 1) Based upon immediate patient need, they can keep the affected trays and discard the Lidocaine at the point of use (a) Merit will provide the customer with warning labels, along with replacement Lidocaine for each affected tray based on their current inventory or (b) The label will instruct the user to dispose of the Lidocaine at the po |
| Quantity | 20, 872 trays |
| Distribution | Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.