Device product
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Z-1531-2018
Product summary
- Event
- Event 79687
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1531-2018
Official wording
Reason: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Code information: 7354908 8005794 8005795 8005796 8010728 8010732 8012784 8012844 8012848 8018509 8019702
Distribution pattern: US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Derived failure modes
-
Unknown
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.