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Recall Observatory FDA recall evidence

Device product

Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

Z-1956-2025

May 15, 2025

Class II

Product summary

Firm
Contamac Solutions, Inc.
Event
Event 96900
Status
Ongoing
Classification
Class II
Quantity
17,273 cartons (604,555 ampoules)
Official record key
device-enforcement:Z-1956-2025

Official wording

Reason: Contact lens insertion solution may lack sterility.

Code information: UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Contact lens insertion solution may lack sterility.