United StatesAlcon Custom Paks—customer-designed sterile ophthalmic surgical procedure packs/convenience kits—bearing catalog numbers 9903-20, 17188-04, 19762-03, 19203-04, and 17957-10 (UDI +H5301ALCON1CPAK10B) and lot numbers 17PJ9X, 17PJAY, 17PU09, 17PMWE, 17PTXP, 17PTXY are recalled. The packs were recalled because they may have incomplete seals that affect sterility; the recall by Alcon Research LLC covers 151 units distributed in CA, ND, and UT.
What's being recalled
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Recalling firm: Alcon Research LLC, Fort Worth, TX, United States.
How to identify it
UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
The hazard
Ophthalmic procedure packs may have incomplete seals affecting sterility.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CA, ND, UT.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)