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U.S. Department of Health and Human Services

Class 2 Device Recall BD Visitec

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  Class 2 Device Recall BD Visitec see related information
Date Initiated by Firm September 16, 2004
Date Posted August 14, 2004
Recall Status1 Terminated 3 on February 17, 2005
Recall Number Z-1344-04
Recall Event ID 29568
510(K)Number K820618  
Product Classification Knife, Ophthalmic - Product Code HNN
Product BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g)
REF 585240
Code Information Lot Numbers: 3182770, 3231212, 3234243, 3238890, 3274064, 3281592, 3318026, 3325843, 3330607, 3344597, 3344633, 4012982, 4033079, 4049076, 4069650, 4084089, 4084102, 4106845, 4125046, 4141947, 4147817
Recalling Firm/
Manufacturer
BD Opthalmic Systems
411 Waverley Oaks Rd Ste 2229
Bldg. 2
Waltham MA 02452-8448
For Additional Information Contact David Cromwick
781-906-7916
Manufacturer Reason
for Recall
Blade may become detached from the handle
FDA Determined
Cause 2
Other
Action BD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement product.
Quantity in Commerce 6945 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.
510(K) Database 510(K)s with Product Code = HNN and Original Applicant = VISITEC CO.
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