Recalls / —
—#143253
Product
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
- FDA product code
- EZL — Catheter, Retention Type, Balloon
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K030813, K063442, K100603
- Affected lot / code info
- Lot Codes: 515359164X
Why it was recalled
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- US (nationwide) and to Canada.
Timeline
- Recall initiated
- 2016-01-22
- Posted by FDA
- 2016-03-21
- Terminated
- 2017-06-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #143253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.