Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
FDA Recall Z-1111-2019 · Posted 2019-04-09
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Recalling FirmBeaver Visitec
Recall StatusTerminated
Product CodeHNN
Date Initiated2019-03-12
Date Terminated2020-08-11
Product Quantity196 boxes (10units/box)
Reason for Recall
Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
Firm Action
Beaver-Visitec International, Inc.(BVI) initiated recall by letter on 3/12/19 advising users of the problem, action to take: immediately examine inventory and quarantine product from this lot subject to mplete and return the enclosed Product Recall Notice Response & Return Form recall, Return ALL quarantined product from the affected lot. Questions you may contact our Customer Service Team at:[email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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