Recall Z-1941-2009 ยท BZA Connector, Airway (Extension)
Teleflex Medical
Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
| Date | Sep 16, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs. |
| Root cause | Process control |
| Action | Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986. |
| Quantity | 569,465 (total for all types) |
| Distribution | U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850964 | DOUBLE-SWIVEL CONNECTOR Sheridan Catheter Corp., May 14, 1985 |