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U.S. Department of Health and Human Services

Class 3 Device Recall BD Visitec EdgeAhead MVR Knife

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  Class 3 Device Recall BD Visitec EdgeAhead MVR Knife see related information
Date Initiated by Firm April 06, 2010
Date Posted May 13, 2010
Recall Status1 Terminated 3 on August 06, 2012
Recall Number Z-1597-2010
Recall Event ID 55254
Product Classification Knife, ophthalmic - Product Code HNN
Product BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA.

Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions.
Code Information Model # 585230, Lot 9202221
Recalling Firm/
Manufacturer		 Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
For Additional Information Contact Steve Bourdon
781-906-7917
Manufacturer Reason
for Recall		 A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918.
FDA Determined
Cause 2		 Packaging process control
Action BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm. For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com.
Quantity in Commerce 1170 (US 810, OUS 360)
Distribution Worldwide Distribution -- United States, Canada and Japan.
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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