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U.S. Department of Health and Human Services

Class 2 Device Recall BD Ophthalmic

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  Class 2 Device Recall BD Ophthalmic see related information
Date Initiated by Firm September 15, 2008
Date Posted October 03, 2008
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0022-2009
Recall Event ID 49436
Product Classification Ophthalmic Cannula - Product Code HMX
Product BD Visitec High Viscosity Injector, 4mm
Ref: 585173. The product is intended for Vitroretinal Surgery.
Code Information Lot Number: 8018591
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		 Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
FDA Determined
Cause 2		 Employee error
Action BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
Quantity in Commerce 1485 units
Distribution AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia 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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