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Recall Observatory FDA recall evidence

Device product

Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

Z-2342-2018

May 14, 2018

Class II

Product summary

Firm
Beaver Visitec
Event
Event 80311
Status
Terminated
Classification
Class II
Quantity
1354 units
Official record key
device-enforcement:Z-2342-2018

Official wording

Reason: Blades are loose in handles and may fall out due to non cured epoxy

Code information: Lot Numbers: 6002436 & 6002663

Distribution pattern: US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Blades are loose in handles and may fall out due to non cured epoxy