Class II

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

ConvaTec, Inc · January 17, 2024

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.

States Affected

AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, TX

Quantity Affected

1,715 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1276-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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