FDA recall Z-0147-2024

Product

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Reason for recall

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Distribution

US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.

Key facts

Status

Ongoing

Initiation date

2023-09-20

Report date

2023-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2024