The Recall Desk
HighFDA (Devices)·Z-0211-2022·Announced 2021-11-17

QuikClot Combat Gauze Recalled for Potential Sterile Packaging Seal Failure

Z-Medica is recalling 2400 units of QuikClot Combat Gauze due to potential packaging seal failures that could compromise sterile barrier integrity. Affected lot 12645 was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with potential for sterile barrier compromise allowing contamination. Although no illnesses or injuries have been reported, the product is used for traumatic wound management where contamination poses a risk of serious infection. The theoretical risk of harm justifies High severity.

Plain-English summary

Z-Medica, LLC is recalling approximately 2400 units of QuikClot Combat Gauze (Model/Part# 200, Lot# 12645) used for temporary external control of traumatic bleeding. The recall addresses a potential lack of packaging seal integrity that may allow the sterile barrier to be compromised.

A compromised sterile barrier could permit bacterial or pathogenic contamination of the gauze prior to use, potentially exposing users and patients to infection. The device is used in traumatic and emergency care settings where wound management is critical.

The affected lot was distributed nationwide within North Carolina. Healthcare facilities, military medical units, and trauma centers that received this lot should verify their inventory against recall lot number 12645.

Customers who possess stock of the recalled lot should discontinue use and return affected units to Z-Medica. Healthcare providers should verify their supply and replace the affected lot with unaffected inventory to ensure continued product safety and integrity.

The recalled product

Product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Manufacturer
Z-Medica, LLC
Category
Medical Device — Hemostasis / Wound Care
Hazard
  • sterile-barrier-breach
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot# 12645 UDI I Primary DI Number: 00841495102004

Distribution

Distributed nationwide across the United States.

Related recalls

Same category