Device product
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
Z-1215-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11400
- Official record key
device-enforcement:Z-1215-2016
Official wording
Reason: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Code information: Lot Codes: 511752564X 516054164X 520853264X 525450264X
Distribution pattern: US (nationwide) and to Canada.
Derived failure modes
-
Unknown
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria