Skip to content
Recall Observatory FDA recall evidence

Device product

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

Z-2519-2021

August 09, 2021

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 88460
Status
Ongoing
Classification
Class II
Quantity
2,734,830 units
Official record key
device-enforcement:Z-2519-2021

Official wording

Reason: There is a potential for open seals which can compromise sterility.

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

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seals which can compromise sterility