Recall Z-0858-2007 ยท BZD Ventilator, Non-Continuous (Respirator)
Teleflex Medical
Infant Nasal CPAP Cannula, Size 1; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1691and 41691 (International): Infant CPAP Set intended fo
| Date | Jun 7, 2007 (initiated Mar 23, 2007) |
| Status | Terminated |
| Reason | The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. |
| Root cause | Other |
| Action | Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the |
| Quantity | 13,530 for all products |
| Distribution | Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Ven |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871157 | C.P.A.P. NASAL CANNULA Hudson Oxygen Therapy Sales Co., Apr 21, 1987 |