Coloplast Recalls Mislabeled Biatain Super Non-Adhesive Wound Dressing Lot
Coloplast is recalling one lot of Biatain Super Non-Adhesive wound dressings due to mislabeling. The affected units were distributed to Missouri and Rhode Island.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The source text identifies the issue as mislabeling without reporting any illnesses or injuries.
Plain-English summary
Coloplast Manufacturing US, LLC is conducting a recall for one lot (4201931) of Biatain Super Non-Adhesive wound dressings. The recall was initiated because the product was mislabeled. The specific product affected is Catalog number 46300, 10 pcs, REF 0463001400, with a country of origin of Hungary.
The affected dressings were distributed to Missouri and Rhode Island. The product is primarily indicated for the treatment of high, medium, and low exuding leg ulcers surrounded by fragile skin, as well as for padding and protection of 2nd degree burns, diabetic wounds, surgical wounds, and skin abrasions.
Consumers who have this specific lot of Biatain Super Non-Adhesive dressings should stop using them and contact Coloplast for further instructions. The source text does not specify the exact nature of the mislabeling or report any illnesses or injuries associated with the product.
The recalled product
- Product
- Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used…
- Manufacturer
- Coloplast Manufacturing US, LLC
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 6
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 (1)
- 4201931
Distribution
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