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U.S. Department of Health and Human Services

Class 3 Device Recall Biatain Super NonAdhesive

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  Class 3 Device Recall Biatain Super NonAdhesive see related information
Date Initiated by Firm September 08, 2014
Date Posted October 24, 2014
Recall Status1 Terminated 3 on January 21, 2015
Recall Number Z-0138-2015
Recall Event ID 69279
Product Classification Dressing,wound,occlusive - Product Code NAD
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.

Code Information 4201931
Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact Customer Care Representative
800-533-0464
Manufacturer Reason
for Recall		 Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
FDA Determined
Cause 2		 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 in Commerce 6
Distribution US Distribution to MO and RI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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