ConvaTec Esteem+ Durahesive Plus ostomy pouches recalled for release liner defect
ConvaTec is recalling 5,284 units of Esteem+ Durahesive Plus ostomy pouches due to impaired release liner functionality. The defect may affect proper device operation for patients managing colostomy or ileostomy output.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is classified as FDA Class II. No hospitalizations, injuries, or illnesses have been reported. The hazard—impaired release liner functionality—presents a risk of device malfunction but without evidence of actual harm reported, placing this at the High severity level.
Plain-English summary
ConvaTec, Inc. is recalling ConvaTec Esteem+ Durahesive Plus Drainable Pouches (19-64mm, REF 416976) distributed nationwide in the United States. The recall involves 5,284 units from batch numbers 2A00585, 2A00586, 2A04528, 2A04529, and 2A04530.
The pouches have been identified with impaired functionality of the release liner. This defect may affect proper pouch operation during use.
The product is intended for management of stoma output following colostomy or ileostomy procedures. Patients and healthcare providers who have used or distributed affected batch numbers should take appropriate action regarding this issue.
Patients currently using affected pouches should contact ConvaTec for instructions regarding discontinuation and replacement options. The FDA is overseeing this recall as a Class II matter.
The recalled product
- Product
- ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Ostomy supplies
- Affected units
- 5,284
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI/DI: 768455115358
- Batch Numbers: 2A00585
- 2A00586
- 2A04528
- 2A04529
- 2A04530m
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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