Device product
Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD TRAY COMPONENTS INCLUDING HAND SANITIZER AND SKIN BARR Item Code: P4P18XCSDK¿¿¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
Z-1218-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300
- Official record key
device-enforcement:Z-1218-2016
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: 524356364X
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