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U.S. Department of Health and Human Services

Class 3 Device Recall QuickCore Ultrasound Biopsy Needle

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  Class 3 Device Recall QuickCore Ultrasound Biopsy Needle see related information
Date Initiated by Firm April 23, 2002
Date Posted October 31, 2003
Recall Status1 Terminated 3 on December 04, 2003
Recall Number Z-0079-04
Recall Event ID 27461
510(K)Number K013356  
Product Classification Biopsy Needle - Product Code FCG
Product EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.
Code Information Lot #1580452, 1583962, 1584813, 1586227, 1587259, 1588313, 1589076, 1590011, 1591358, 1594584 (under hold in finished goods), and 1592359.
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
4900 Bethania Station Rd
& 5951 Grassy Creek Blvd.
Winston-Salem NC 27105
For Additional Information Contact Jessica Hughes
336-744-0157
Manufacturer Reason
for Recall		 There is a possibility that the affected devices would not capture a biopsy during a procedure.
FDA Determined
Cause 2		 Other
Action On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.
Quantity in Commerce 129 units
Distribution Units were distributed to medical facilities nationwide, UK and Israel
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 = FCG and Original Applicant = WILSON-COOK MEDICAL, INC.
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