FDA Device recall Z-1209-2016
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…
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of 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… 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1209-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-22 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
Product
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
Reason
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Identifiers
| code_info | Lot Codes: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X…Lot Codes: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X 522550264X 522950064X 524353064X 525450164X 525752564X |
|---|
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-1209-2016%22
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