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Recall Observatory FDA recall evidence

Device product

Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection

Z-1936-2016

March 25, 2016

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 73828
Status
Terminated
Classification
Class II
Quantity
176,000 units
Official record key
device-enforcement:Z-1936-2016

Official wording

Reason: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Code information: Catalog (REF #) 9004476, Lot #4163707

Distribution pattern: Nationwide Distribution to NY only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.