HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
This recall has been terminated (originally issued December 28, 2007).
- Recall Initiated
- August 22, 2007
- Posted
- December 28, 2007
- Terminated
- August 13, 2012
- Recall Number
- Z-0211-2008
- Quantity
- 215,656 units
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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)
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.
Lot / Code Info
Product Code/Catalog Number: 1770; Lot Numbers: 49069, 50069, 51069, 52069, 53069, 01079, 02079, 03079, 04079, 06079, 12079, 1279R, 13079, 15079, 16079, 17079, 17079R, 18079, 19079, 19079R and 20079. PRODUCT CODE/CATALOG NUMBER: 41770, Lot Numbers: 50069, 52069, 01079, 06079, 16079, 17079, 17079R, and 18079.
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
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.