FDA Medical Device Recalls (openFDA)
Contamac Solutions, Inc.: Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
- Recall number
- Z-0030-2022
- Recalling firm
- Contamac Solutions, Inc.
- Product
- Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
- Status
- Terminated
- Initiated
- 2021-07-27
- Posted
- not on file
- Terminated
- 2023-06-07
- Reason
- Contact lens solution may contain foreign material
- Root cause
- Device Design
- Action
- 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
- Quantity
- 104335 vials
- 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, serial or model codes
- Lot Number: FOE
- 510(k) numbers
- ["K181566"]
- PMA numbers
- not on file
- Product code
- MRC
- Firm FEI
- 3016114779
- Firm city
- Grand Junction
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28