Z-2795-2020 Class II Terminated
FDA device recall Z-2795-2020 was initiated by Bioseal Corporation on August 15, 2019 and is designated Class II. 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 t… The recall status is terminated (terminated March 4, 2021). Affected quantity: 900 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- August 15, 2019
- Termination Date
- March 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 units
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.
Distribution Pattern
US Nationwide distribution including in the state of CA.
Code Information
Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476