Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile… — Class II medical device recall Z-1204-2016
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 number | Z-1204-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2016-01-22 |
| Classified | 2016-03-21 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 20,400 |
| Reason classes | microbial contamination |
| Lot numbers | 513256364X, 514555864X, 516050164X, 516852964X, 517456764X |
| Model numbers | P400, P4P14SD |
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
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-1204-2016. 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.