ESTEEM SYNERGY recallZ-0903-2025 · ConvaTec, Inc · initiated Nov 29, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
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 satisfactory information, formal authorization from a firm Representative will be provided to proceed with product destruction. 4) Firm will provide a Certificate of Destruction (COD) to complete. 5) Immediately destroy all affected product and provide firm with a signed Certificate of Destruction (COD) as evidence to support reconciliation and regulatory reporting. 6) Complete and return the response form via email to [email protected] 9. Your account will be credited for destroyed product upon receipt of the response form and Certificate of Destruction (COD). If you need any further information or support concerning this recall, please contact any of the following [email protected], [email protected] or telephone 800-582-6514.
Recall details
- Recall number
- Z-0903-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 29, 2024
- Posted by the FDA
- Jan 10, 2025
- Recalling firm
- ConvaTec, Inc
- Quantity
- 240
- Product code
- EXE
- Distribution
- US distribution to states of: OH, NY, IL
Product description
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
Code information (models, lots, serial numbers)
REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ESTEEM SYNERGY 405473Convatec, Purchasing Department · PROTECTOR, OSTOMY1 recall0 reports
- ESTEEM SYNERGY 405479Convatec, Purchasing Department · PROTECTOR, OSTOMY1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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