Z-0260-2024 Class II Ongoing
FDA device recall Z-0260-2024 was initiated by Alcon Research, LLC on September 7, 2023 and is designated Class II. Reason for recall: Custom surgical procedure packs contain latex gloves but are labeled as "latex free". The recall status is ongoing. Affected quantity: 120 packs.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 packs
Product Description
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Reason for Recall
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
Distribution Pattern
US: VA OUS: None
Code Information
LOT # : 160NMU, UDI: (01)10380653302278