Recall Z-1201-2016— Covidien LLC

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2016-01-22, terminated 2017-06-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients. Reason: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria.

Recalling firm
Covidien LLC
Classification
Class II
Status
Terminated
Initiated
2016-01-22
Terminated
2017-06-20
Firm location
North Haven, CT, United States

Product description

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.