FDA Recalls Easy Care First Aid Kit for Bacterial Contamination
The FDA is recalling Easy Care First Aid Kits with contaminated After Burn Cream packets distributed nationwide and in Canada. Lab testing identified Bacillus lichenformis and Bacillus sonorensis contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity of 4 per regulatory guidelines. The contamination of a topical wound-care product with pathogenic bacteria represents a serious health hazard, though no illnesses have been reported in the source material.
Plain-English summary
The FDA is recalling Easy Care First Aid 25 Person 2009 ANSI First Aid Kits manufactured by GFA Production Xiamen Co. Ltd. The kits contain Easy Care After Burn Cream packets (product number 9999-2132) that have been found to be contaminated with Bacillus lichenformis and Bacillus sonorensis. FDA laboratory testing identified the microbial contamination.
The kits were distributed nationwide and in Canada. The affected lot is W06H15 with an expiration date of August 15, 2024. Approximately 8,280 packets are subject to this recall.
The FDA classified this as a Class I recall, indicating a serious health hazard. Consumers should not use the affected cream packets.
The recalled product
- 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
- Manufacturer
- GFA Production Xiamen Co. Ltd.
- Category
- Drug — Topical / Wound Care
- Affected units
- 8,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # W06H15
- exp 08/15/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by GFA Production Xiamen Co. Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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