FDAFDA · Food and drugs·Recall number Z-2612-2017
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as 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
Published June 28, 2017 · Recall initiated: May 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging breach may compromise sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Z-Medica, LLC
- Distributor
- Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
- Lot
- Lot # 7313
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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