Bioseal Trachea Extender 1/pl 50pk/Cs recall
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…
Why was Bioseal Trachea Extender 1/pl 50pk/Cs recalled?
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476
- 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…
- Recalling firm
- Bioseal Corporation
- Quantity
- 900 units
- Distribution
- US Nationwide distribution including in the state of CA.
- Recall date
- August 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)