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.
What this means for you
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
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
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