Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Nutrifill

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Nutrifillsee related information
Date Initiated by FirmMay 15, 2025
Date PostedJune 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1956-2025
Recall Event ID 96900
510(K)NumberK181566 
Product Classification Products, contact lens care, rigid gas permeable - Product Code MRC
ProductContamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Code Information UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK
Recalling Firm/
Manufacturer		 Contamac Solutions, Inc.
806 Kimball Ave
Grand Junction CO 81501-3842
For Additional Information ContactContamac Soluntions Support
1303-500-0561
Manufacturer Reason
for Recall		Contact lens insertion solution may lack sterility.
FDA Determined
Cause 2		Process control
ActionOn 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 discarding). Please contact recall@contamacsolutions.com to initiate a return. 4. Complete the Customer Response form. If you are having trouble accessing the form, please reach out to recall@contamacsolutions.com for assistance. 5. Provide the recall notification to all those who need to be aware, including others within your organization or to any organization where the affected devices may have been transferred. 6. Distributors - If you have further distributed the product, please provide this recall notification to those distributors and ask them to provide a copy to their customer.
Quantity in Commerce17,273 cartons (604,555 ampoules)
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MRC
-
-