FDA Medical Device Recalls (openFDA)
Coloplast Manufacturing US, LLC: 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.
- Recall number
- Z-0138-2015
- Recalling firm
- Coloplast Manufacturing US, LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-09-08
- Posted
- 2014-10-24
- Terminated
- 2015-01-21
- Reason
- Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
- Root cause
- Labeling mix-ups
- Action
- Coloplast sent an "Urgent Voluntary Recall Notification" dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If they have further distributed the product they need to contact their customers immediately. For questions they can contact Coloplast Customer Care Representative at 800-533-0464. A second follow up "Urgent Voluntary Recall Notification" letter dated September 23, 2014 was also sent to consignees.
- Quantity
- 6
- Distribution
- US Distribution to MO and RI.
- Lot, serial or model codes
- 4201931
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAD
- Firm FEI
- 2125050
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28