ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Summary
The FDA issued a Class II for ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, by ConvaTec, Inc. Reason: The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring..
Details
Source
Device Recall
External ID
Z-1276-2024
Action Date
2024-03-13
Status
Ongoing
Category
device
Product Description
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Lot/Code Info: Lot #2C02496, UDI-DI #00768455116096.
Quantity Affected: 1,715 units
Reason for Recall
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Distribution
Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-17
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 225 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-1276-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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