Recall Z-0211-2008 ยท CAF Nebulizer (Direct Patient Interface)
Teleflex Creek Dr
HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
| Date | Dec 28, 2007 (initiated Aug 22, 2007) |
| Status | Terminated |
| Reason | Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient) |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Customers were notified by an Urgent Medical Device Recall letter on/about 08/22/2007. They were instructed to return the affected products to Teleflex Medical or acknowledge that the products no longer exist. In addition, each were instructed to forward the letter if they have further distributed into institutional settings or to homecare patients and retrieve relevant product from those locations. This recall is to the consumer/user level via sub-recall from distributors or direct accounts as per the Recalling firm. |
| Quantity | 215,656 units |
| Distribution | Worldwide: USA, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Germany, Guatemala, India, Mexico, Panama, Peru, Philippines, South Korea, Thailand, United Arab Emirates, and The United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K772348 | NEBULIZER ADAPTER Respiratory Care, Inc., Jan 3, 1978 |