Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk
Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect poses a 'serious heath risk to patient' by preventing prescribed ventilation, which aligns with the rubric criterion for Severe (4) involving significant injury reports or serious health risks.
Plain-English summary
Bioseal Corporation is recalling 900 units of Bioseal Trachea Extenders (REF TRAX01/50) distributed nationwide in the United States, including California. The affected lots are 400453, 400456, 400461, 400472, and 400476. These airway connectors are intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
The recall was initiated because a stress crack was reported in the port of the swivel elbow where the flip cap is inserted. This defect could result in leakage from the breathing system, which may prevent the prescribed ventilation from being delivered to the patient. The source text notes that these cracks could pose a serious health risk if they reach a significant size.
Healthcare facilities and consumers should stop using the affected products immediately. Bioseal Corporation is the recalling firm responsible for this action.
The recalled product
- Product
- Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube…
- Manufacturer
- Bioseal Corporation
- Affected units
- 900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453
- 400456
- 400461
- 400472
- 400476
Distribution
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