Z-0030-2022 Class II Terminated
FDA device recall Z-0030-2022 was initiated by Contamac Solutions, Inc. on July 27, 2021 and is designated Class II. Reason for recall: Contact lens solution may contain foreign material The recall status is terminated (terminated June 7, 2023). Affected quantity: 104335 vials.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- July 27, 2021
- Termination Date
- June 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104335 vials
Product Description
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 Pattern
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
Code Information
Lot Number: FOE