Medical Device Recall: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P
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.
Product Description
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
Distribution
Worldwide distribution.
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2610-2024
Status: ongoing
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