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Recall Observatory FDA recall evidence

Device product

T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

Z-1195-2017

January 18, 2017

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 76292
Status
Terminated
Classification
Class II
Quantity
772 boxes
Official record key
device-enforcement:Z-1195-2017

Official wording

Reason: The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

Code information: lots: 11157523, 11158179, 11158180, 11159101, 11159729

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    package of the blister that may compromise the sterility