Device product
BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Z-2750-2017
Product summary
- Event
- Event 77513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 340,000 units
- Official record key
device-enforcement:Z-2750-2017
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: 6090832 2021-03 6176715 2021-06
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.