Z-1200-2016 Class II Terminated
FDA device recall Z-1200-2016 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: 118400 kits.
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
- 118400 kits
Product Description
Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA 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: 518151164X 519450564X 520850264X 521250764X 522951064X 525150364X 525251064X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1200-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026