ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpu
Summary
The FDA issued a Class II for ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 4 by ConvaTec, Inc. Reason: impaired functionality of the release liner.
Details
Source
Device Recall
External ID
Z-0127-2023
Action Date
2022-11-02
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI/DI: 768455115358, Batch Numbers: 2A00585, 2A00586, 2A04528, 2A04529, 2A04530m
Quantity Affected: 5284 units
Reason for Recall
impaired functionality of the release liner
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-16
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 128 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-0127-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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