Device product
Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
Z-1220-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16500
- Official record key
device-enforcement:Z-1220-2016
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: 511059164X 511851264X 515358364X 516853364X 517457264X 520150864X 522958264X 525153564X
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