Z-1531-2018 Class II Terminated
FDA device recall Z-1531-2018 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¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
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
7354908 8005794 8005795 8005796 8010728 8010732 8012784 8012844 8012848 8018509 8019702
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1531-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026