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…
Alcon Research LLC · Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch co…
Open FDA's page for this record- Cfres ID
- 212476
- Product res number
- Z-1293-2025
- Event date initiated
- 2025-02-10
- Event date posted
- 2025-03-06
- Recall status
- Open, Classified
- Res event number
- 96285
- Product code
- LRO
- Firm FEI number
- 1610287
- Recalling firm
- Alcon Research LLC
- Address 1
- 6201 South Fwy
- City
- Fort Worth
- State
- TX
- Postal code
- 76134-2099
- Additional info contact
- Kristen Kellerhals 817-551-4047
- Root cause description
- Software design
- Product quantity
- 2511
- Distribution pattern
- US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
- Product description
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
- Code info
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.
- Action
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
- K numbers
- K880961
- Harmonized identifiers (openFDA)
- Device name
- General Surgery Tray
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4370
- Device class
- 2
- K number
- K883250, K971061, K894685, K925214, K934688, K931824, K930270, K871437, K932221, K970286, K890729, K932220, K842648, K910365, K932217, K882684, K922133, K934030, K934428, K931758, K914037, K925016, K885090, K941846, K925216, K963721, K936117, K931844, K884093, K892389, K935686, K874439, K952539, K963443, K926269, K934029, K893814, K881083, K871873, K212258 +70 more
- Registration number
- 2000028362, 3011144486, 3041276890, 9616088, 3013298431, 3004122598, 9611024, 3005997949, 3015058854, 8030672, 1650907, 3006673317, 3014421917, 3002806603, 2029015, 3014925393, 3004361903, 1061124, 1055236, 3004362278, 8022032, 3019798849, 1610287, 3016761372, 3044906632, 3013421458, 3006400329, 3004111573, 3009750712, 3013466775, 3006271008, 1066741, 1420054, 2936485, 3015960676, 8030678, 3008403546, 3031841433, 3006191977, 3036002406 +125 more
- FEI number
- 2000028362, 3011144486, 3041276890, 3008373372, 3013298431, 3004122598, 1000113384, 1000160458, 3005997949, 3002805559, 3015058854, 3014421917, 3002807170, 3002806603, 3014925393, 1000208624, 2523865, 3003094575, 3004361903, 3004362278, 3019798849, 1610287, 3016761372, 3932, 3044906632, 3003015552, 3013421458, 3003803331, 3006400329, 3004111573, 3009750712, 3013466775, 3006271008, 3001236905, 1420054, 1000117501, 2936485, 3015960676, 3008403546, 3031841433 +125 more