Z-1890-2018Class II

Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475

Name: Z-1890-2018 Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475
Creator: ConvaTec, Inc
Published: 2018-04-25
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2018-04-25 / Terminated / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier... on 2018-04-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1890-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-25
Posted: 2018-05-16
Terminated: 2023-02-27
Recalling firm: ConvaTec Limited
Product: 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.
Product code: MMH Blood Establishment Computer Software And Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ConvaTec sent an Urgent Voluntary Medical Device Recall dated April 20, 2018. Customers were directed to inspect their inventory, perform a count of affected product, and respond even if none of the recalled product was found. Once the response is received, return instructions will be provided. Distributors were directed to perform a sub-account recall, forwarding the letter to their customers. The firm will be providing replacement product.
Quantity in commerce: 200 boxes of 10
Distribution: US Nationwide Distribution
Product codes and lots: Lot Number 7F00987

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1890-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1890-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-16

Product code MMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)