Recall Z-0505-2013 ยท EOQ Bronchoscope (Flexible Or Rigid)
ConMed Corporation
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral 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 spec
| Date | Dec 10, 2012 (initiated Nov 20, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914181 | WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE Mill-Rose Laboratory, Dec 10, 1991 |