RecallRadar

FDA Device recall Z-1212-2016

Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and fema…

On 2016-03-30 the FDA classified a Class II recall of Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and fema… by Covidien, citing aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1212-2016
ClassificationClass II
Statusterminated
Initiated2016-01-22
Published2016-03-30
Last updated2026-09-13 11:54 UTC
CompanyCovidien
DistributionUS

Product

Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients

Reason

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

Identifiers

code_infoLot Codes: 513256264X 515358164X 517457064X 520550064X 520857464X 521058564X 522958064X 525153264X

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1212-2016%22

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