Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.
FDA Recall Z-0046-2007 · Posted 2006-10-19
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2006-08-11
Date Terminated2007-12-04
Product Quantity71 units.
Reason for Recall
The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
Firm Action
Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
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.