Recall Z-2519-2021— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2021-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955). Reason: There is a potential for open seals which can compromise sterility..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-08-09
- Firm location
- Greensboro, NC, United States
Product description
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Reason for recall
There is a potential for open seals which can compromise sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.