Z-1227-2016 Class II Terminated
FDA device recall Z-1227-2016 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: 9200.
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
- 9200
Product Description
Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD 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: 512550564X 513256764X 515358564X 522551364X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1227-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026