Z-1533-2018 Class II Terminated
FDA device recall Z-1533-2018 was initiated by Becton Dickinson & Company on Mar 20, 2018 and is designated Class II. Reason for recall: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. The recall status is terminated (terminated Apr 20, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Mar 20, 2018
- Termination Date
- Apr 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Reason for Recall
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Distribution Pattern
US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Code Information
7348980
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1533-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026