Class I

Medical Device Recall: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025

Smiths Medical ASD Inc. · May 29, 2024

Reason for Recall

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

Distribution

Worldwide distribution.

Quantity Affected

3138 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2590-2024

Status: ongoing

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