PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 30, 2016 Initiated: January 22, 2016 #Z-1218-2016

Product Description

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

Reason for Recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Details

Recalling Firm
Covidien LLC
Units Affected
300
Distribution
US (nationwide) and to Canada.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by Covidien LLC. Units affected: 300.
Why was this product recalled?
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Which agency issued this recall?
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1218-2016.