FDA-Device2020-04-15Class II
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.
Bard Peripheral Vascular Inc
Hazard
Sterility compromised due to packaging pouches that may not be sealed properly
Sold states
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.
Affected count
8,170 units (US: 420 and OUS: 7,750)
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2020Don't want to check this manually?
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