Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall Z-1200-2016 · Posted 2016-03-21
Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeKOY
Date Initiated2016-01-22
Date Terminated2017-06-20
Product Quantity118400 kits
Reason for Recall
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Firm Action
Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.
For questions regarding this recall call 203-492-5000.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US (nationwide) and to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.