Device product
Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
Z-1205-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3000
- Official record key
device-enforcement:Z-1205-2016
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: 520858064X
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