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Recall Observatory FDA recall evidence

Device product

Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients

Z-1202-2016

January 22, 2016

Class II

Product summary

Firm
Covidien LLC
Event
Event 73121
Status
Terminated
Classification
Class II
Quantity
207000
Official record key
device-enforcement:Z-1202-2016

Official wording

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

Code information: Lot Codes: 513287864X 514688164X 518187764X 520288464X 523087364X

Distribution pattern: US (nationwide) and to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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