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Terminated

Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

FDA Recall Z-0930-05 · Posted 2005-06-25

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2005-04-26
Date Terminated2005-10-26
Product Quantity48

Reason for Recall

The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.

Firm Action

Consignees were notified via letter dated 4/26/05.

Root Cause

Other

Distribution Pattern

Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914088BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBEBivona Medical Technologies · 1991-10-23

Official Source

View FDA Recall →

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

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