Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh

FDA device recall Z-0903-2025 · posted 2025-01-10 · Open, Classified

Recall details

Recalling firm

ConvaTec, Inc

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

EXE

Quantity affected

240

Distribution

US distribution to states of: OH, NY, IL

Date initiated

2024-11-29

Date posted

2025-01-10

Location

Greensboro, NC