Z-1209-2016 Class II Terminated
FDA device recall Z-1209-2016 was initiated by Covidien LLC on Jan 22, 2016 and is designated Class II. Reason for recall: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria The recall status is terminated (terminated Jun 20, 2017). Affected quantity: 83400.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2016
- Initiation Date
- Jan 22, 2016
- Termination Date
- Jun 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83400
Product Description
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 for Recall
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Distribution Pattern
US (nationwide) and to Canada.
Code Information
Lot Codes: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X 522550264X 522950064X 524353064X 525450164X 525752564X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1209-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026