Device product
BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Z-2753-2017
Product summary
- Event
- Event 77513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,528,000 units
- Official record key
device-enforcement:Z-2753-2017
Official wording
Reason: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Code information: 6061746 2021-02 6082982 2021-02 6089821 2021-03 6117858 2021-04 6117863 2021-04 6117889 2021-04 6117891 2021-04 6146962 2021-04 6173697 2021-05 6173767 2021-06 6173779 2021-06 6208614 2021-07
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.