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Terminated

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

FDA Recall Z-2740-2018 · Posted None

Recalling FirmBeaver Visitec
Recall StatusTerminated
Product CodeHNN
Date Initiated2018-06-18
Date Terminated2019-10-30
Product Quantity440

Reason for Recall

Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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