Recall Z-1851-2014 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
| Date | Jun 23, 2014 (initiated May 23, 2014) |
| Status | Terminated |
| Reason | Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label. |
| Root cause | Error in labeling |
| Action | Teleflex Medical sent a Urgent Medical Device Recall Notification dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above from the lot numbers listed on the attachment. 2. To return product, complete the enclosed Recall |
| Quantity | 1658 ea |
| Distribution | Nationwide Distribution and the country of Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935842 | RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE Rusch, Inc., May 23, 1995 |