medical MODERATE Updated 2024-03-13

ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Affected States: AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, TX
Lot/Code Info: Lot #2C02496, UDI-DI #00768455116096.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

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