FDA recall Z-0380-2022

Product

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Reason for recall

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

Distribution

US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.

Key facts

Status

Terminated

Initiation date

2021-11-09

Report date

2021-12-22

Termination date

2023-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foothill Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0380-2022