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U.S. Department of Health and Human Services

Class 2 Device Recall Beaver Visitec International, Inc

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  Class 2 Device Recall Beaver Visitec International, Inc see related information
Date Initiated by Firm May 01, 2015
Date Posted June 15, 2015
Recall Status1 Terminated 3 on January 28, 2021
Recall Number Z-1803-2015
Recall Event ID 71293
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584648
Ophthalmic surgical kits
Code Information Lot Numbers:  3038787 3046210 3061080 3078492 3093681 3095940 3108668 
Recalling Firm/
Manufacturer		 Beaver-Visitec International Inc.
411 Waverley Oaks Rd Ste 229
Waltham MA 02452-8422
For Additional Information Contact SAME
781-906-7950
Manufacturer Reason
for Recall		 Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950.
Quantity in Commerce 384 kits
Distribution Nationwide Distribution including KY, GA, MI, and NJ.
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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