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Class 2 Device Recall BD Ophthalmic |
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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
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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
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For Additional Information Contact |
SAME 781-906-7950
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Manufacturer Reason for Recall |
Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
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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
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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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