FDA recall Z-2324-2021

Product

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

Reason for recall

CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

Distribution

US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.

Key facts

Status

Ongoing

Initiation date

2021-07-09

Report date

2021-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rocklin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2021