Z-2519-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 9, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,734,830 units
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.
Distribution Pattern
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.
Code Information
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