Device product
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Z-2740-2018
Product summary
- Firm
- Beaver Visitec
- Event
- Event 80565
- Status
- Terminated
- Classification
- Class II
- Quantity
- 440
- Official record key
device-enforcement:Z-2740-2018
Official wording
Reason: Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Code information: Lot Number 6001700
Distribution pattern: Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
Derived failure modes
-
Labeling or packaging
Mislabel