Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0525-2018·Announced 2018-02-14

ConvaTec Recalls Mislabelled Ostomy Skin Barrier Products

ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a minor labeling error involving a mislabeled outer box for a medical device, which fits the rubric criteria for a moderate severity recall.

Plain-English summary

ConvaTec, Inc. is recalling a portion of Lot 7H02242 outer boxes of the SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar (10 pack, 45 mm, REF 411802). The recall involves 47,630 units, which equates to 4,763 market units.

The recall was initiated because the outer boxes were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803). The product is intended for use as an ostomy protector providing a protective barrier to patient skin.

The affected units were distributed nationwide to Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, and Wisconsin. Consumers should check their inventory for Lot 7H02242 and contact ConvaTec for further instructions.

The recalled product

Product: SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
Manufacturer: ConvaTec, Inc
Category: Medical Device — Ostomy Care
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot 7H02242

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Same manufacturer · ConvaTec, Inc

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