Recall Z-0233-2020— ConvaTec, Inc
Class II · Terminated
Class II FDA medical device recall by ConvaTec, Inc, initiated 2019-09-06, terminated 2022-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management. Reason: ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-06
- Terminated
- 2022-11-30
- Firm location
- Greensboro, NC, United States
Product description
Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
Reason for recall
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.