Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 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-1199-2016
- Quantity
- 74300 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: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X
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.