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
Reported: June 28, 2017 Initiated: May 17, 2017 #Z-2612-2017
Product Description
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
Reason for Recall
Packaging breach may compromise sterility
Details
- Recalling Firm
- Z-Medica, LLC
- Units Affected
- 2910 pieces
- Distribution
- Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
- Location
- Wallingford, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Z-Medica, LLC. Units affected: 2910 pieces.
Why was this product recalled? ▼
Packaging breach may compromise sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2017. Severity: Moderate. Recall number: Z-2612-2017.
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