Recall Z-2714-2014 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Teleflex Medical
Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
| Date | Sep 30, 2014 (initiated Sep 8, 2014) |
| Status | Terminated |
| Reason | The pediatric breathing circuits can crack prior to and during use. |
| Root cause | Device Design |
| Action | Teleflex Medical sent an Urgent Medical Device Recall dated September 8, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, quarantine any products with the product codes and lot numbers provided in the notification, return any affected product, complete and return the enclosed Recall Acknowledgement Form and fax it to the attention of Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990. |
| Quantity | 27,176 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.