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Recall Observatory FDA recall evidence

Device product

VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.

Z-0835-2013

February 01, 2013

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 64321
Status
Terminated
Classification
Class II
Quantity
192,000 pieces (192 cases)
Official record key
device-enforcement:Z-0835-2013

Official wording

Reason: The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.

Code information: Lot No. 12H27

Distribution pattern: US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.