Recall Z-0030-2022 ยท MRC Products, Contact Lens Care, Rigid Gas Permeable
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
| Date | Jul 27, 2021 |
| Status | Terminated |
| 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 disca |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181566 | Nutrifill Contamac, Ltd., Oct 22, 2018 |