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U.S. Department of Health and Human Services

Class 3 Device Recall Laborie Transducer Cartridge

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  Class 3 Device Recall Laborie Transducer Cartridge see related information
Date Initiated by Firm October 04, 2006
Date Posted December 01, 2006
Recall Status1 Terminated 3 on May 18, 2007
Recall Number Z-0229-2007
Recall Event ID 36743
Product Classification Urology Transducer Cartridge - Product Code FEN
Product Laborie Transducer Cartridge with Luer Lock
Reference: DIS130
Code Information Lot Numbers: 36G20M41 and 36H03M005
Recalling Firm/
Manufacturer		 Laborie Medical Technologies
400 Ave. D Suite 10
Williston VT 05495
For Additional Information Contact Barbara Monet
802-857-1300
Manufacturer Reason
for Recall		 Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041
FDA Determined
Cause 2		 Other
Action Laborie Medical telephoned Customers on 10/4-5/06 and advised they were sent product DIS130 with Lot # 36G20M41 and or #36H03M005 were incorrectly labeled with expiration date and lacked lot number on the pouch label. Directions were provided for product return.
Quantity in Commerce 2,625 units
Distribution Worldwide-USA including states of AR, CA, FL, KY, MA, NY, OK, TX and Country of Canada: Laborie Medical Montreal, Canada Laborie Medical Toronto, Canada
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.
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