Wallingford, CT, United States
Z-Medica, LLC recalls
2 recalls recorded since 2018, most recently on 22 September 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 September 2021
- Terminated
- 11 June 2024
- Reason
- Lack of Packaging seal integrity may result in a sterile barrier breach.
- Distribution
- US Nationwide distribution in the state of NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0211-2022
- QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Terminated Class II Medical devices
- Recall started
- 17 November 2017
- Terminated
- 4 June 2018
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0925-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.