Class 2 Device Recall QuikClot Trauma Pad

• Date Initiated by Firm: November 17, 2017
• Create Date: March 08, 2018
• Recall Status: Terminated on June 04, 2018
• Recall Number: Z-0925-2018
• Recall Event ID: 79407
• 510(K)Number: K123387
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
• Code Information: Part# 460, Lot# 7397
• FEI Number: 3004138549
• Recalling Firm/ Manufacturer: Z-Medica, LLC; 4 Fairfield Blvd; Wallingford CT 06492-1857
• For Additional Information Contact: Joseph Azary; 203-294-0000 Ext. 230
• Manufacturer Reason for Recall: A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).
• FDA Determined Cause: Mixed-up of materials/components
• Action: On November 22, 2017 an URGENT ADVISORY NOTICE was issued to customers stating the following: The QuikClot TraumaPad is packaged with 10 pouches in a carton. This lot may contain some pouches that incorrectly identify the product as QuikClot Roll. All pouches (identified as TraumaPad or Roll) are identified with the correct Part N umber (REF 460), Lot Number, and Expiration Date for QuikClot TraumaPad, and contain the QuikClot TraumaPad product. Please note that the labeling on the cartons is also correct and we believe that this only impacts a small num ber of pouches. In addition, QuikClot TraumaPad and QuikCot Roll have the identical ingredients, chemical composition, indications for use, packaging material and surface area. The only difference is that the QuikClot TraumaPad is a 12 inch x 12 inch, 3-ply pad and the QuikClot Roll is a 3 inch x 4 yard roll. Both products are equally effective in being used to stop bleeding. This was the result of an isolated operator error. Please note that actions have been taken to prevent this issue in the future and further corrective actions are under review. Ifyou have any inventory of this lot number, you may choose to use the prod uct as the correct prod uct is packaged into each pouch (only pouch labeling is incorrect). Ifyou chose to destroy the prod uct or have any questions regardi ng this matter, please contact us at the email and telephone number below.
• Quantity in Commerce: 4890
• Distribution: Nationally
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = FRO