FDA recall Z-0563-2022

Product

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Reason for recall

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

Distribution

US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.

Key facts

Status

Ongoing

Initiation date

2022-01-24

Report date

2022-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2022