Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area f
FDA device recall Z-1201-2016 · posted 2016-03-21 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KOY
- Quantity affected
- 18000 kits
- Distribution
- US (nationwide) and to Canada.
- Date initiated
- 2016-01-22
- Date posted
- 2016-03-21
- Date terminated
- 2017-06-20
- Location
- North Haven, CT
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