Device product
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Z-1597-2016
Product summary
- Event
- Event 73767
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6597 packs
- Official record key
device-enforcement:Z-1597-2016
Official wording
Reason: The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
Code information: Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.