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Recall Observatory FDA recall evidence

Device product

Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.

Z-1689-2020

March 17, 2020

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 85338
Status
Terminated
Classification
Class II
Quantity
8,170 units (US: 420 and OUS: 7,750)
Official record key
device-enforcement:Z-1689-2020

Official wording

Reason: Sterility compromised due to packaging pouches that may not be sealed properly

Code information: Lot Numbers: 0001303256 and 0001303257

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility compromised