Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
FDA Recall Z-0582-05 · Posted 2005-03-10
Advertisement
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTR
Date Initiated2005-01-14
Date Terminated2005-08-19
Product Quantity8,990 units
Reason for Recall
Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
Firm Action
The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers.
Root Cause
Other
Distribution Pattern
Nationwide
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.
Advertisement