Recall Z-0138-2015— Coloplast Manufacturing US, LLC
Class III · Terminated
Class III FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2014-09-08, terminated 2015-01-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Coloplast Manufacturing US, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-09-08
- Terminated
- 2015-01-21
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.