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U.S. Department of Health and Human Services

Class 2 Device Recall WANG Transbronchial Aspiration Needles

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 Class 2 Recall
WANG Transbronchial Aspiration Needles
see related information
Date Posted December 10, 2012
Recall Status1 Open
Recall Number Z-0502-2013
Recall Event ID 63728
Premarket Notification
510(K) Number
K914181 
Product Classification Bronchoscope (Flexible Or Rigid) - Product Code EOQ
Product WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Code Information Begining Lot 1207251, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210151. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).
Recalling Firm/
Manufacturer
ConMed Corporation
525 French Road
Utica, New York 13502
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact M. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall
ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502 United Sates of America For information regarding this recall call 315-624-3225.
Quantity in Commerce Total 452
Distribution Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = MILL-ROSE LABORATORY
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