Recall Z-0233-2020 ยท EXE Protector, Ostomy
ConvaTec, Inc
Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
| Date | Sep 6, 2019 |
| Status | Terminated |
| Reason | ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring. |
| Root cause | Process control |
| Action | The firm began notifying their consignees by telephone on 09/06/2019 and followed with a letter on 09/11/2019. The letter identifies the products and lots involved, describes the problem and states that Convatec will accept product returns of affected product. |
| Quantity | 8,008131 skin barriers |
| Distribution | Worldwide distributions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.