Recall record at a glance
| Official record | Z-0138-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Report date | Nov 5, 2014 |
| Recall initiation date | Sep 8, 2014 |
| Quantity | 6 |
| Location | Minneapolis, MN, United States |
Official product description
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 throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.
Why the product was recalled
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Distribution information
US Distribution to MO and RI.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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