PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 18, 2021 Initiated: June 23, 2021 #Z-2248-2021

Product Description

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.

Details

Units Affected
560 devices
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
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm. Recalled by Bard Peripheral Vascular Inc. Units affected: 560 devices.
Why was this product recalled?
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2248-2021.