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U.S. Department of Health and Human Services

Class 2 Device Recall Beaver Xstar Slit Knife

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  Class 2 Device Recall Beaver Xstar Slit Knife see related information
Date Initiated by Firm March 12, 2019
Date Posted April 09, 2019
Recall Status1 Terminated 3 on August 11, 2020
Recall Number Z-1111-2019
Recall Event ID 82382
Product Classification Knife, ophthalmic - Product Code HNN
Product 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
Code Information Lot Number: 6008554
Recalling Firm/
Manufacturer		 Beaver Visitec
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information Contact SAME
781-906-7950
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 196 boxes (10units/box)
Distribution Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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