Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD 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-1209-2016
- Quantity
- 83400
- 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: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X 522550264X 522950064X 524353064X 525450164X 525752564X
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.