Z-1890-2018 Class II Terminated
FDA device recall Z-1890-2018 was initiated by ConvaTec, Inc on Apr 25, 2018 and is designated Class II. Reason for recall: It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label. The recall status is terminated (terminated Feb 27, 2023). Affected quantity: 200 boxes of 10.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Apr 25, 2018
- Termination Date
- Feb 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 boxes of 10
Product Description
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
Reason for Recall
It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Number 7F00987
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1890-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026