Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
FDA Recall Z-0302-06 · Posted 2005-12-23
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2005-02-17
Date Terminated2007-12-04
Product Quantity26
Reason for Recall
The word PED was printed on the neckflange instead of the word NEO.
Firm Action
Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.
Root Cause
Other
Distribution Pattern
Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
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.