FDA Recall D-0251-2023
GFA Production Xiamen Co. Ltd. · Xiamen, N/A
Class I — life-threatening Terminated 949 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
Reason for recall
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recall record
- Recall number
D-0251-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide and Canada.
- Recall initiated
- 2022-12-23
- Classified by FDA Center
- 2023-01-27
- FDA published
- 2023-02-08
- Terminated
- 2025-07-29
- Recalling firm
- GFA Production Xiamen Co. Ltd.
- Firm location
- Xiamen, N/A, China