Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
This recall has been terminated (originally issued July 27, 2021).
- Company
- Contamac Solutions, Inc.
- Recall Initiated
- July 27, 2021
- Terminated
- June 7, 2023
- Recall Number
- Z-0030-2022
- Quantity
- 104335 vials
- Firm Location
- Grand Junction, CO
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot Number: FOE
Root Cause
Device Design
Action Taken
On 8/5/2021, Contamac, issued a "Urgent: Medical Device recall" notification to affected consignees. In addition to informing consignees about the recall product, Contamac asked consignees to take the following actions: 1. Refer to the package label and Product Distribution Information below to verify the product is impacted (i.e. lot FOE). 2. Immediately discontinue use of impacted product 3. Destroy and discard the product (i.e. remove vial cap and empty contents before discarding) 4. Notify us using the following link to confirm that you received this recall notification and have discarded impacted product: Customer Form 5. If you have questions, please contact Toll-Free: 1-833-266-8262, Telephone: 1-970-985-4240, E-Mail: hello@nutrifill.com, Hours: M-F 9:00 am - 5:00 pm MDT 6. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA: Online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm or, Call FDA 1-800-FDA-1088