Recall Z-2598-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-2598-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-29

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2024-05-29. It names one FDA 510(k) clearance: K912469. Product: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60. Reason: 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-05-29
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K912469 — BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBEBivona Medical Technologies·cleared 1991-06-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.