Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
FDA Recall Z-0394-06 · Posted 2006-01-18
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2005-12-16
Date Terminated2007-02-08
Reason for Recall
Sterility is compromised by incomplete package seal.
Firm Action
Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
Root Cause
Other
Distribution Pattern
Nationwide and Canada.
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.