# FDA recall Z-2612-2017

> **Z-Medica, LLC** · Class II · device recall initiated 2017-05-17.

## Product

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

## Distribution

Worldwide Distribution - US (Nationwide)  Foreign: South Korea, Taiwan, Thailand

## Key facts

- **Recall number:** Z-2612-2017
- **Recalling firm:** Z-Medica, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-17
- **Report date:** 2017-06-28
- **Termination date:** 2018-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wallingford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2017

## Citation

> AI Analytics. FDA recall Z-2612-2017. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2612-2017. Source: US FDA. Licensed CC0.

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