Recall Z-0903-2025 ยท EXE Protector, Ostomy
ConvaTec, Inc
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
| Date | Jan 10, 2025 (initiated Nov 29, 2024) |
| Status | Open, Classified |
| Reason | Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding |
| Root cause | Process control |
| Action | On 11/29/2024, "URGENT: MEDICAL DEVICE RECALL" notices were emailed to customers who were asked to do the following: 1) Review this notification and ensure all relevant stakeholders are aware of this recall communication and any action required. 2) If you have distributed affected product beyond your establishment, identify your customers, and notify them at once of this product recall. Your notification to your customers can be enhanced by including a copy of this recall notification letter. 3) Immediately examine your inventory and quarantine affected product Upon receipt and review of sat |
| Quantity | 240 |
| Distribution | US distribution to states of: OH, NY, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.