FDA recall Z-1422-2018

Carefusion 2200 Inc · Class II · device

Product

JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Distribution

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

Key facts

Status
Terminated
Initiation date
2017-02-23
Report date
2018-04-25
Termination date
2019-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1422-2018