Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh
Summary
The FDA issued a Class II for Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two- by ConvaTec, Inc. 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 wafer.
Details
Source
Device Recall
External ID
Z-0903-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
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
Lot/Code Info: REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814
Quantity Affected: 240
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
Distribution
US distribution to states of: OH, NY, IL
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-29
Company
Greensboro, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ConvaTec, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ConvaTec, Inc have FDA actions?
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0903-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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