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U.S. Department of Health and Human Services

Class 2 Device Recall EBI

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 Class 2 Device Recall EBIsee related information
Date Initiated by FirmJune 17, 2003
Date PostedJuly 15, 2003
Recall Status1 Terminated 3 on December 31, 2003
Recall NumberZ-1006-03
Recall Event ID 26512
510(K)NumberK023233 K971083 K982484 K010179 
Product Classification Endoscope, Neurological - Product Code GWG
ProductEBI VueCath Endoscopic Spinal System
Code Information Catalog Number: S002 Lot/Serial Nos: F10021, F10017, F10012, F10018, F10025, F10019, F10020, F10014, F10023, F10022, F10001, F10000, F10024, F10007, F10008, F00005, F10003, F10016, F10015, F10002, F10027.
FEI Number 2242816
Recalling Firm/
Manufacturer		 EBI, L.P.
100 Interpace Parkway
Parsippany NJ 07054-1079
For Additional Information ContactBarry Sands
973-331-3904
Manufacturer Reason
for Recall		Non sterile device is labeled sterile.
FDA Determined
Cause 2		Labeling False and Misleading
ActionThe firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.
Quantity in Commerce39
DistributionHospitals, clinics, and doctors nationwide.
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.
510(K) Database510(K)s with Product Code = GWG
510(K)s with Product Code = GWG
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