DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
- Company
- Convatec, Inc
- Recall Initiated
- August 9, 2021
- Recall Number
- Z-2519-2021
- Quantity
- 2,734,830 units
- Firm Location
- Greensboro, NC
Reason for Recall
There is a potential for open seals which can compromise sterility.
Distribution
International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakistan, Paraguay, Qatar, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, Uruguay, USA and Vietnam.
Lot / Code Info
ICC 187660 - Lots 9B02984Y, 9G04308, 9K05775, 9L00556, 0A03460, and 9A04124Y ICC 187957 - Lots 9J02859, 9H02226, 9H04865, 9L02456 ICC 187955 - Lots 9L01731, 9L04890, 9K02656, 9H01234, 9M01779, and 9H00183
Root Cause
Process control
Action Taken
Customer notification was made via email and via UPS letter. Distributors are asked to stop distributing and quarantine all recalled lots. All customers are notified that a Recall Response Form is to be completed and returned to the recalling firm. All impacted product is to be returned via third party Sedgwick, Indianapolis, IN. If product was further distributed, the customer shall forward the recall notification letter and ask subaccounts to follow the recall instructions.