Recall Z-0138-2015 ยท NAD Dressing, Wound, Occlusive
Coloplast Manufacturing US, LLC
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 f
| Date | Oct 24, 2014 (initiated Sep 8, 2014) |
| Status | Terminated |
| Reason | Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled. |
| Root cause | 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 | 6 |
| Distribution | US Distribution to MO and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.