FDAFDA · Food and drugs·Recall number Z-1276-2024
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Published March 13, 2024 · Recall initiated: January 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConvaTec, Inc
- Distributor
- 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.
- Lot
- Lot #2C02496, UDI-DI #00768455116096.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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