Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients
This recall has been terminated (originally issued March 21, 2016).
- Company
- Covidien Llc
- Recall Initiated
- January 22, 2016
- Posted
- March 21, 2016
- Terminated
- June 20, 2017
- Recall Number
- Z-1201-2016
- Quantity
- 18000 kits
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Distribution
US (nationwide) and to Canada.
Lot / Code Info
Lot Codes: 512590564X 516087864X 517488664X 518889264X 520288264x 521689164X
Root Cause
Nonconforming Material/Component
Action Taken
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.