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.
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- September 8, 2014
- Posted
- October 24, 2014
- Terminated
- January 21, 2015
- Recall Number
- Z-0138-2015
- Quantity
- 6
- Firm Location
- Minneapolis, MN
Reason for Recall
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Distribution
US Distribution to MO and RI.
Lot / Code Info
4201931
Root Cause
Labeling mix-ups
Action Taken
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.
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