Recall Z-0723-2023 ยท FRO Dressing, Wound, Drug
ConvaTec, Inc
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
| Date | Dec 19, 2022 (initiated Nov 15, 2022) |
| Status | Open, Classified |
| Reason | ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings. |
| Root cause | Process control |
| Action | The firm issue an URGENT; VOLUNTARY MEDICAL DEVICE RECALL to its consignees by UPS Ground on 11/15/2022. The notice explained the problem and requested the following actions: "DISTRIBUTOR ACTIONS 1 Immediately stop distributing and quarantine all recalled lots. 2 Perform a count of recalled product currently in inventory. Complete the enclosed response form (Attachment 1) and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. 3 Call toll free number 888-364-2995. You will be assigned an RGA number and given i |
| Quantity | 5300 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE Convatec, Inc., Jun 6, 2013 |