Device product
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Z-1532-2018
Product summary
- Event
- Event 79687
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1532-2018
Official wording
Reason: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Code information: 7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925
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.