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

September 16, 2016

Class II

Product summary

Firm: Becton Dickinson & Company
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
reason.no_named_rule · v1.0.0

BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.