FDA-Device2016-03-30Class II

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

Covidien LLC
Hazard

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Sold states
US (nationwide) and to Canada.
Affected count
83400
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1209-2016

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