Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons
Dukal Corp. is recalling sterile Blue Burn Sheets because intact cartons were found to contain shredded sheets, compromising the sterile barrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation that may cause temporary or medically reversible health consequences. The hazard is a sterile barrier failure, which is a significant quality issue but does not involve reported injuries or high-risk pathogens.
Plain-English summary
Dukal Corp. is recalling sterile Blue Burn Sheets, Item 7305, because intact cartons were found to contain shredded burn sheets. The product is intended to provide a sterile barrier environment to protect patients from infection. The presence of shredded material within intact packaging indicates a failure in the sterile barrier integrity.
The recall affects 12,095 cases of the 60" x 96" Blue Burn Sheets. Distribution was worldwide, including nationwide in the United States and in Canada. Specific lot numbers are listed in the official recall record.
Healthcare facilities and consumers should stop using the affected products and contact Dukal Corp. for further instructions or a return.
The recalled product
- Product
- BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
- Manufacturer
- Dukal Corp.
- Category
- Medical Device — Surgical Drapes
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 (20)
- Lot Numbers: JT13607
- JT17507
- JT35207
- JT09008
- JT11308
- JT15408
- JT18408
- JT18708
- JT23408
- JT24508
- JT26408
- JT28408
- JT31408
- JT33508
- JT00609
- JT04809
- JT15209
- JT18209
- JT19209
- JT22409
Distribution
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