Z-0138-2015 Class III Terminated
FDA device recall Z-0138-2015 was initiated by Coloplast Manufacturing US, LLC on Sep 8, 2014 and is designated Class III. Reason for recall: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled. The recall status is terminated (terminated Jan 21, 2015). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 5, 2014
- Initiation Date
- Sep 8, 2014
- Termination Date
- Jan 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
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.
Reason for Recall
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Distribution Pattern
US Distribution to MO and RI.
Code Information
4201931
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0138-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026