HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
FDA Recall Z-0211-2008 · Posted 2007-12-28
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Recalling FirmTeleflex Creek Dr
Recall StatusTerminated
Product CodeCAF
Date Initiated2007-08-22
Date Terminated2012-08-13
Product Quantity215,656 units
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)
Firm 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.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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