Device 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 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.
Z-0138-2015
Product summary
- Event
- Event 69279
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6
- Official record key
device-enforcement:Z-0138-2015
Official wording
Reason: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Code information: 4201931
Distribution pattern: US Distribution to MO and RI.
Derived failure modes
-
Labeling or packaging
mislabeled