FDA recall Z-2342-2018

Beaver Visitec · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-05-14
Report date
2018-07-11
Termination date
2021-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2342-2018