Device product

BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

Z-2747-2017

September 16, 2016

Class II

Product summary

Firm: Becton Dickinson & Company
Event: Event 77513
Status: Terminated
Classification: Class II
Quantity: 22,400 units
Official record key: device-enforcement:Z-2747-2017

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: 6204878 2021-07

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.