FDA Device Recall Z-2591-2024

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;

Lot / serial / GTIN: a) UDI/DI 15021312005691, Product Code/List Number/Item Code 60N030, Serial Numbers: 3853477, 3868292, 3877665, 3884248, 3904659, 3930047, 3949025, 3952381, 3955770, 3965339, 3965340, 4006289, 4051641, 4066298, 4080798, 4089297, 4110464, 4128036, 4138992, 4159934, 4171560, 4196292, 4204824, 4206834, 4212788, 4233976, 4254268, 4286813, 4331629, 4335053, 4348776, 4353055, 4358515, 4381032, 4388201, 4389921; b) UDI/DI 15021312005707, Product Code/List Number/Item Code 60N035, Serial Numbers: 3880712, 3904683, 3911437, 3946267, 3949046, 3952351, 4006291, 4023792, 4048023, 4056228, 4077083, 4086032, 4096829, 4107578, 4119113, 4136144, 4151019, 4161994, 4171561, 4180455, 4212789, 4237394, 4260075, 4279346, 4331630, 4335054, 4348749, 4348780, 4348781, 4388202, 4389922; c) UDI/DI 15021312005714, Product Code/List Number/Item Code 60N040, Serial Numbers: 3868302, 3884255, 3907990, 3931153, 3949023, 3952346, 3962603, 3982698, 3988169, 4015574, 4051633, 4089296, 4107569, 4128033, 4142419, 4156652, 4176206, 4209580, 4221355, 4233978, 4238778, 4286814, 4345040, 4362872

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.

Recall record

Recall number: Z-2591-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution.
Recall initiated: 2024-05-29
Classified by FDA Center: 2024-08-23
FDA published: 2024-09-04
Recalling firm: Smiths Medical ASD Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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