Recall Z-1293-2025
Alcon Research LLC · initiated February 10, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
Codes / lots: UDI-DI: H5301ALCON1CPAK10. Pak/Lot(Expiration): 12771-18/JZ5190507(3/31/2025); 18050-10/JZ5200922(5/31/2025), JZ5202199(9/30/2025); 18252-17/JZ5200852(5/31/2025); 12698-09/JZ5201264(6/30/2025); 15632-10, JZ5202447(6/30/2025), JZ5202445(6/30/2025); 3141-45/ JZ5201303(7/31/2025), JZ5201305(7/31/2025); 12630-07/ JZ5201295(8/31/2025); 18925-05/JZ5194816(9/30/2025), JZ5194818(9/30/2025), JZ5196180(9/30/2025), JZ5196182(9/30/2025), JZ5200323(11/30/2025); 19265-05/JZ5201146(9/30/2025), JZ5201148(9/30/2025), JZ5202207(9/30/2025); 13894-16/JZ5201181(9/30/2025), JZ5202143(9/30/2025); 17550-08/JZ5198232(10/31/2025); 12236-18/JZ5201054(11/30/2025); 11854-15/JZ5201561(11/30/2025); 8043-29/JZ5202201(11/30/2025); 12466-17/JZ5205311(12/31/2025), JZ5205313(12/31/2025), JZ5205915(1/31/2026); 15599-17/JZ5205311(12/31/2025), JZ5205313(12/31/2025), JZ5205915(1/31/2026); 14764-09/JZ5197158(2/28/2026); 13194-16/JZ5197142(3/31/2026); 17069-09/JZ5201931(9/30/2026)
Reason for recall
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
FDA-determined cause: Software design
Action taken
On 2/10/2025, correction notices were mailed to customers who were asked to do the following: 1) Do not open packaging. Using the provided stickers, adhere one sticker to the outside of affected product near the label to identify it as containing latex. 2) Complete and return the response form electronically via: https://qrco.de/non-latex-symbol Should you have any questions or concerns about this matter, please feel free to call the firm at A 1-800-862-5266
Details
- Recall number
- Z-1293-2025
- Initiated
- February 10, 2025
- Posted by FDA
- March 6, 2025
- Product code
- LRO – General Surgery Tray
- Quantity
- 2511
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
- Recalling firm
- Alcon Research LLC, Fort Worth, TX