Easy Care First Aid Kit Recalled for Microbial Contamination
The FDA is recalling Easy Care First Aid kits containing After Burn Cream due to microbial contamination. The affected product was distributed nationwide and in Canada with lot number W06H15 (expiration August 15, 2024).
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: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls must be scored no lower than 4, regardless of other factors. No deaths or serious injuries have been reported.
Plain-English summary
The FDA is recalling Easy Care First Aid 10 Person 2009 ANSI First Aid Kits containing Easy Care first aid After Burn Cream in 0.9 g packets (Product # 9999-2131), manufactured by GFA Production Xiamen Co. Ltd. The recalled product was distributed nationwide and in Canada, with lot number W06H15 and expiration date of August 15, 2024.
FDA laboratory testing found the product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. These microorganisms were detected in the non-sterile product.
The recalled product
- Product
- Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131
- Manufacturer
- GFA Production Xiamen Co. Ltd.
- Category
- Drug — Topical Medication
- Affected units
- 7,200
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
Same manufacturer · GFA Production Xiamen Co. Ltd.
See all →- SevereFDA Recalls First Aid Cream Packets Over Bacterial Contamination
FDA (Drugs) · 2023-02-08
- SevereFDA Recalls Easy Care First Aid Kit for Bacterial Contamination
FDA (Drugs) · 2023-02-08
- SevereFDA Recalls Easy Care First Aid Kits for Bacterial Contamination
FDA (Drugs) · 2023-02-08
- SevereFirst Aid Kit Product Recalled Due to Bacterial Contamination
FDA (Drugs) · 2023-02-08
- CriticalEasy Care First Aid Kit Recalled for Bacterial Contamination
FDA (Drugs) · 2023-02-08
Same hazard · bacillus lichenformis
See all →- SevereCVS First Aid Home Burn Cream Packets Recalled for Bacterial Contamination
FDA (Drugs) · 2023-02-08
- CriticalFirst Aid Kit with Burn Cream Recalled for Bacterial Contamination
FDA (Drugs) · 2023-02-08
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