—#143109

Product

Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients

FDA product code: KOY — Degreaser, Skin, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Codes: 513256364X 514555864X 516050164X 516852964X 517456764X

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 #143109. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.