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Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm… recallZ-0930-05 · Smiths Medical ASD, Inc. · initiated Apr 26, 2005

Terminated All recalls posted in June 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number
Z-0930-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 26, 2005
Posted by the FDA
Jun 25, 2005
Recalling firm
Smiths Medical ASD, Inc.
Quantity
48
Product code
JOH
FDA submissions
K914088
Distribution
Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.

Product description

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

Code information (models, lots, serial numbers)

Lot G651610.

Other devices under the same FDA submission

19 devices cleared under K914088 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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