Z-1225-2016 Class II Terminated
FDA device recall Z-1225-2016 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: 25080.
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
- 25080
Product Description
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD 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: 511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1225-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026