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Recall Observatory FDA recall evidence

Device product

3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

Z-2007-2019

February 01, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 82138
Status
Terminated
Classification
Class II
Quantity
460,800
Official record key
device-enforcement:Z-2007-2019

Official wording

Reason: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

Code information: Lot Number 8303571

Distribution pattern: The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.