FDA-Device2016-03-30Class II
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
Covidien LLC
Hazard
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Sold states
US (nationwide) and to Canada.
Affected count
300
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1218-2016Don't want to check this manually?
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