Recall Z-2795-2020— Bioseal Corporation
Class II · Terminated
Class II FDA medical device recall by Bioseal Corporation, initiated 2019-08-15, terminated 2021-03-04. FDA's recall record names no specific 510(k) clearance for this event. 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, tracheostomy tube, or mask.. Reason: 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..
- Recalling firm
- Bioseal Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-15
- Terminated
- 2021-03-04
- Firm location
- Placentia, CA, United States
Product description
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, tracheostomy tube, or mask.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.