FDA-Device2017-07-26Class II

BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

Becton Dickinson & Company
Hazard

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

Sold states
Nationwide Distribution
Affected count
547,600 units
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2752-2017

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