WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 2
FDA device recall Z-0503-2013 · posted 2012-12-10 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- 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.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- EOQ
- Quantity affected
- 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.
- Date initiated
- 2012-11-20
- Date posted
- 2012-12-10
- Date terminated
- 2015-08-25
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE (K914181) | Mill-Rose Laboratory | 1991-12-10 |