ConvaTec, Inc Recall 88460
Description: DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
ConvaTec, Inc Recall 88460 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2519-2021 |
| Event ID | 88460 |
| Event Description | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) |
| Product Type | Devices |
| 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. |
| Quantity | 2,734,830 units |
| Recall Reason | There is a potential for open seals which can compromise sterility. |
| Device Classification | 20210929 |
| Device 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 |
| Center Classification Date | 20210923 |
| Recall Initiation Date | 20210809 |
| Recalling Firm | ConvaTec, Inc |
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