Recall Z-1350-2024 ยท FON Bag, Drainage, With Adhesive, Ostomy
ConvaTec, Inc
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
| Date | Mar 21, 2024 (initiated Feb 19, 2024) |
| Status | Open, Classified |
| Reason | Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld. |
| Root cause | Under Investigation by firm |
| Action | ConvaTec issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its consignees on 02/19/2024 via email. The notice explained the problem and requested the consignee quarantine the affected product and respond. Upon receipt, the firm will issue a Certificate of destruction and request the destruction of the product. The notice be shared with the correct individual with the organization and disseminated to all who need to be aware and distributors were directed to notify their customers. |
| Quantity | 6709 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Italy, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.