Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Cus

FDA device recall Z-0980-2014 · posted 2014-02-20 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

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.

Action taken

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 point of use and replace it with the new lot. 2) They may return all affected trays remaining in inventory to Merit for credit or replacement. Consignees were requested to complete and sign the Customer Response Form and immediately fax a copy of the completed Customer Response Form to Joyce Braxton at 1-801-316-4852 and mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. If you choose to return the trays, please return the trays as instructed on the Customer Response Form. If customers choose to keep the trays, Merit can send them labels and Lidocaine upon receipt of the Customer Response Form. If you have any questions, please call 1-804-416-1048 and/or 1-801-316-4822. For questions regarding this recall call 804-416-1030.

Root cause

Other

Status

Terminated

Product code

NGT

Quantity affected

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.

Date initiated

2013-09-30

Date posted

2014-02-20

Date terminated

2014-05-13

Location

Chester, VA