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.
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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
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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
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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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