FDA recall Z-0030-2022

Contamac Solutions, Inc. · Class II · device

Product

Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

Reason for recall

Contact lens solution may contain foreign material

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-07-27
Report date
2021-10-13
Termination date
2023-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Junction, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0030-2022