Product Wiki · Recalls · U.S. FDA — Device Enforcement

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/ — recall Z-2594-2024

U.S. FDA — Device Enforcement · United States · 2024-05-29 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2594-2024
Date of alert: 2024-05-29
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Smiths Medical ASD Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15021312516685

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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