Device product
BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Z-2749-2017
Product summary
- Event
- Event 77513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57600 units
- Official record key
device-enforcement:Z-2749-2017
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: 6117580 2021-03
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.