Recall Z-0260-2024
Alcon Research, LLC · initiated September 7, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Codes / lots: LOT # : 160NMU, UDI: (01)10380653302278
Reason for recall
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
FDA-determined cause: Nonconforming Material/Component
Action taken
On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks.
Details
- Recall number
- Z-0260-2024
- Initiated
- September 7, 2023
- Posted by FDA
- November 7, 2023
- Product code
- LRO – General Surgery Tray
- Quantity
- 120 packs
- Distribution
- US: VA OUS: None
- Recalling firm
- Alcon Research, LLC, Houston, TX