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U.S. Department of Health and Human Services

Class 2 Device Recall BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps

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  Class 2 Device Recall BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps see related information
Date Initiated by Firm July 07, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-2433-2008
Recall Event ID 49094
Product Classification Ophthalmic Forceps - Product Code HNR
Product BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile
Ref: 581440

Used during cataract and other ophthalmic surgery procedures to grasp lens capsule.
Code Information Lot Number: 8067450 Exp. Date: March 2011
Recalling Firm/
Manufacturer		 Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
For Additional Information Contact SAME
781-906-7950
Manufacturer Reason
for Recall		 Metal particulates present.
FDA Determined
Cause 2		 Manufacturing material removal
Action BD notified customers by telephone via a script on July 7, 2008 and requested customers to examine their inventory, dispose of product, and replacement product would be provided.
Quantity in Commerce 260 units
Distribution Nationwide Distribution --- including states of CA, IL, KY, MS, PA, and TX.
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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