# FDA recall Z-0925-2018

> **Z-Medica, LLC** · Class II · device recall initiated 2017-11-17.

## Product

QuikClot TraumaPad, Part# 460 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

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).

## Distribution

Nationally

## Key facts

- **Recall number:** Z-0925-2018
- **Recalling firm:** Z-Medica, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2018-03-14
- **Termination date:** 2018-06-04

- **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-0925-2018

## Citation

> AI Analytics. FDA recall Z-0925-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0925-2018. Source: US FDA. Licensed CC0.

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