510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2750-2017Class II

BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD...

Becton Dickinson & Co / initiated 2016-09-16 / Terminated / root cause: manufacturing process

Becton Dickinson & Company began a recall of 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... on . FDA classified it as Class II and gives the reason as "BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2750-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
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
Product code
FMF Syringe, Piston
Reason for recall
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
BD sent recall letter/return response form on 9/16/2016.
Quantity in commerce
340,000 units
Distribution
Nationwide Distribution
Product codes and lots
6090832 2021-03 6176715 2021-06

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2750-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2747-2017Class IITerminatedVoluntary: Firm initiated
Z-2748-2017Class IITerminatedVoluntary: Firm initiated
Z-2749-2017Class IITerminatedVoluntary: Firm initiated
Z-2750-2017Class IITerminatedVoluntary: Firm initiated
Z-2751-2017Class IITerminatedVoluntary: Firm initiated
Z-2752-2017Class IITerminatedVoluntary: Firm initiated
Z-2753-2017Class IITerminatedVoluntary: Firm initiated