ConvaTec, Inc: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

Hazard

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

Details from the source

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. Quantity: 1,715 units Lot/code info: Lot #2C02496, UDI-DI #00768455116096.

UPC codes

00768455116096

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.