Recall Z-0525-2018— ConvaTec, Inc
Class II · Terminated
Class II FDA medical device recall by ConvaTec, Inc, initiated 2017-10-26, terminated 2023-02-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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)..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-26
- Terminated
- 2023-02-03
- Firm location
- Greensboro, NC, United States
Product description
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.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.