FDA-Device2021-08-18Class II

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Bard Peripheral Vascular Inc
Hazard

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

Sold states
U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
Affected count
560 devices
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2021

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