QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

Class I - Dangerous
🏥 Medical Devices Recalled: September 22, 2021 Z-Medica Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot# 12645 UDI I Primary DI Number: 00841495102004
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Z-Medica, LLC
Reason for Recall:
Lack of Packaging seal integrity may result in a sterile barrier breach.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

Product Codes/Lot Numbers:

Lot# 12645 UDI I Primary DI Number: 00841495102004

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0211-2022

Related Recalls

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).

Nov 17, 2017 Surgical Instruments View Details →

Packaging breach may compromise sterility

May 17, 2017 Surgical Instruments Nationwide View Details →