Reported Feb 14, 2018 · Terminated
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 7H02242
- Amount recalled
- 47,630 units (4,763 market units, 10 per pack)
Where it was sold
Why it was recalled
A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
This product could cause temporary or reversible health problems — stop using it.
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