Z-0211-2008

HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only...

Name: Z-0211-2008 HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only...
Creator: Teleflex Creek Dr
Published: 2007-08-22
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2007-08-22 / Terminated

FDA source

Teleflex Creek Dr began a recall of HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709 on 2007-08-22. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0211-2008
Status: Terminated
Initiated: 2007-08-22
Posted: 2007-12-28
Terminated: 2012-08-13
Recalling firm: Teleflex Medical
Product: HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
Product code: CAF Nebulizer (Direct Patient Interface)
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)
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code CAF

K772348Class IINebulizer AdapterRespiratory Care, Inc. / cleared 1978-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)