FDA Enforcement
Class III
Terminated
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: Z-0138-2015
·
Reported November 5, 2014
Enforcement
- Recall Number
- Z-0138-2015
- Event ID
- 69279
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Coloplast Manufacturing US, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2014
- Initiation Date
- September 8, 2014
- Classification Date
- October 24, 2014
- Termination Date
- January 21, 2015
- Address
- 1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States
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
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Code Info
4201931
Distribution
US Distribution to MO and RI.
Quantity
6