Z-1532-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- March 20, 2018
- Termination Date
- April 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
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
7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925