Device product
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
Z-1223-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95700
- Official record key
device-enforcement:Z-1223-2016
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: 511059464X 511851964X 513256664X 514650264X 515358464X 516050764X 516858564X 517457464X 520151064X 521058864X 522551264X 522958464X 523657064X 524357064X 525755764X 525755864X
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