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Terminated

Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.

FDA Recall Z-0395-06 · 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.

K922665BIVONA HYPERFLEX TRACHEOSTOMY TUBEBivona Medical Technologies · 1993-01-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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