Data Foundry

Medical device recalls 2016

Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD… — Class II medical device recall Z-1210-2016

Terminated recall by Covidien LLC, reported 2016-03-30, distributed nationwide. Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated wit

Recall numberZ-1210-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCovidien LLC, North Haven, CT, United States
Recall initiated2016-01-22
Classified2016-03-21
Reported by FDA2016-03-30
Terminated2017-06-20
DistributedNationwide (US)
Countries outside the USCA
Quantity7,200
Reason classesmicrobial contamination
Lot numbers520858164X, 525756164X
Model numbersP4P16TSD

Product

Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1210-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.