ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, ...
FDA Recall #Z-1276-2024 — Class II — January 17, 2024
Product Description
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
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.
Recalling Firm
ConvaTec, Inc — Greensboro, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,715 units
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.
Code Information
Lot #2C02496, UDI-DI #00768455116096.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated