ClearanceBrief
Recall Z-2740-2018 ยท HNN Knife, Ophthalmic

Beaver Visitec

Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

DateJun 18, 2018
StatusTerminated
ReasonMislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Root causePackaging process control
ActionBVI issued PRODUCT RECALL NOTICES to customers dated June 11, 2018. Customers were instructed to inspect stock, quarantine and destroy product per internal procedures. BVI is kindly asking the customers to provide objective evidence of product destruction so that a credit can be applied to accounts. Customers are also encouraged to complete and return the response form. If you have questions regarding this recall please call Customer Service at 866-906-8080.
Quantity440
DistributionDistribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.