FDA Device recall Z-0138-2015
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400
- FDA Device
- Class III
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class III recall of Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400 by Coloplast Manufacturing Us, citing coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0138-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-09-08 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coloplast Manufacturing Us |
| Distribution | MO, RI |
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.
Reason
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Identifiers
| code_info | 4201931 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2015%22
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