FDA Enforcement
Class II
Terminated
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Recall: Z-1533-2018
·
Reported May 2, 2018
Enforcement
- Recall Number
- Z-1533-2018
- Event ID
- 79687
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 2, 2018
- Initiation Date
- March 20, 2018
- Classification Date
- April 26, 2018
- Termination Date
- April 20, 2020
- Address
- 1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States
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
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Code Info
7348980
Distribution
US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Quantity
N/A