Recall Z-1956-2025 ยท MRC Products, Contact Lens Care, Rigid Gas Permeable
Contamac Solutions, Inc.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
| Date | Jun 11, 2025 (initiated May 15, 2025) |
| Status | Open, Classified |
| Reason | Contact lens insertion solution may lack sterility. |
| Root cause | Process control |
| Action | On May 15, 2025, Contamac Solutions issued a Urgent Medical Device Recall Notification via Email. In addition, the firm issued a press release concerning the recall on the Contamac Solutions, Inc. eCommerce website . Contamac Solutions ask consignees to take the following actions: 1. Refer to the package label and Product Distribution Information to verify the product is impacted. 2. Immediately quarantine and discontinue use of impacted product 3. Please either return any unused product to Contamac Solutions or destroy and discard the product (i.e. remove vial cap and empty contents before |
| Quantity | 17,273 cartons (604,555 ampoules) |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, FL, IL, IN, KS, KY, LA, ME, MI, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181566 | Nutrifill Contamac, Ltd., Oct 22, 2018 |