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U.S. Department of Health and Human Services

Class 3 Device Recall Visitec

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  Class 3 Device Recall Visitec see related information
Date Initiated by Firm March 02, 2007
Date Posted March 29, 2007
Recall Status1 Terminated 3 on March 05, 2008
Recall Number Z-0672-2007
Recall Event ID 37533
Product Classification cataract surgical instrument - Product Code KYG
Product BD Visitec Irrigating Cytosome, for use in cataract surgery.
Ref 581618
Code Information Lot Number: 6181868
Recalling Firm/
Manufacturer		 Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
For Additional Information Contact David Cromwick
781-906-7950
Manufacturer Reason
for Recall		 Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
FDA Determined
Cause 2		 Other
Action BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
Quantity in Commerce 1500 units
Distribution Nationwide.
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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