FDA recall Z-2248-2021

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2021-06-23

Report date

2021-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

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