Z-1197-2016 Class II Terminated
FDA device recall Z-1197-2016 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: 16500 units.
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
- 16500 units
Product Description
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 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: 522959464X 525757064X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1197-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026