Alcon Custom Pak surgical kits recalled for possible sterility loss
Alcon Custom Pak sterile surgical procedure packs used in eye surgery may have incomplete seals that could compromise sterility. This affects 151 units across specific lot numbers. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check your inventory for Custom Pak units with lot numbers 17PJ9X, 17PJAY, 17PU09, 17PMWE, 17PTXP, or 17PTXY
- Do not use affected packs for surgical procedures
- Contact Alcon Research LLC for instructions on replacement or return
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 151 units
- Illnesses reported
- None reported
- Manufactured in
- 6201 South Fwy, N/A, Fort Worth, TX, United States
- Classification
- Class I
- Recall number
- Z-0939-2026
In the FDA's words
- Description
- 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 Ophthalmic procedure packs may have incomplete seals affecting sterility. 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 Distribution: US Nationwide distribution in the states of CA, ND, UT. Affected quantity: 151 units
- Hazard
- Ophthalmic procedure packs may have incomplete seals affecting sterility.