Recall Z-1111-2019 ยท HNN Knife, Ophthalmic
Beaver Visitec
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
| Date | Apr 9, 2019 (initiated Mar 12, 2019) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Packaging process control |
| 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:ClaimsUS@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday). |
| Quantity | 196 boxes (10units/box) |
| Distribution | Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.