510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2740-2018Class II

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

Becton Dickinson & Co / initiated 2018-06-18 / Terminated / root cause: packaging

Beaver Visitec began a recall of Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery on . FDA classified it as Class II and gives the reason as "Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-2740-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Product code
HNN Knife, Ophthalmic
Reason for recall
Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
BVI 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.
Quantity in commerce
440
Distribution
Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
Product codes and lots
Lot Number 6001700

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2740-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2740-2018Class IITerminatedVoluntary: Firm initiated