Class 2 Device Recall Esteem Synergy Stomahesive Skin Barrier

• Date Initiated by Firm: November 29, 2024
• Date Posted: January 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0903-2025
• Recall Event ID: 95955
• Product Classification: Protector, ostomy - Product Code EXE
• Product: 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: REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7815 National Service Rd Ste 600; Greensboro NC 27409-9403
• For Additional Information Contact: 336-547-3730
• Manufacturer Reason for Recall: 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 Determined 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 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 fsca-id@convatec.com 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 fsca-id@convatec.com, us.customerservice@convatec.com or telephone 800-582-6514.
• Quantity in Commerce: 240
• Distribution: US distribution to states of: OH, NY, IL
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.