Recall Z-0504-2013
ConMed Corporation · initiated November 20, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 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.
Codes / lots: Begining Lot 11207241, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210081. 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).
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: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0504-2013
- Initiated
- November 20, 2012
- Posted by FDA
- December 10, 2012
- Terminated
- August 25, 2015
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Quantity
- 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.
- Recalling firm
- ConMed Corporation, Utica, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0502-2013 Class II | WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central…ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles… | 11/20/2012Terminated |
| Z-0503-2013 Class II | WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central…ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles… | 11/20/2012Terminated |
| Z-0505-2013 Class II | WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central…ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles… | 11/20/2012Terminated |