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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 Ophthalmicsee related information
Date Initiated by FirmFebruary 28, 2006
Date PostedMarch 15, 2006
Recall Status1 Terminated 3 on September 13, 2006
Recall NumberZ-0613-06
Recall Event ID 34715
Product Classification Knife, Ophthalmic - Product Code HNN
ProductBD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728
Code Information Lot Number: 5335524
FEI Number 1211998
Recalling Firm/
Manufacturer		 BD Opthalmic Systems
411 Waverley Oaks Road
Waltham MA 02452-8448
For Additional Information ContactDavid Cromwick
781-906-7916
Manufacturer Reason
for Recall		Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife
FDA Determined
Cause 2		Other
ActionBD Ophthalmic notifIed customers by telephone on 2/28/06 requesting users to examine product and return mislabeled product.
Quantity in Commerce3430 units
DistributionNationwide Foreign: Belgium
Total Product Life CycleTPLC 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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