Recall Z-2795-2020 ยท BZA Connector, Airway (Extension)
Bioseal Corporation
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.
| Date | Aug 15, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | On 8/15/2019, the firm sent an "Urgent: Medical Device Recall" letter via email followed up by phone calls to its customers to inform them the firm is voluntarily recalling product that has been affected by an urgent medical device recall from Intersurgical, Inc. There appears to be a potential portal crack with the Swivel Elbow component where the flip cap is inserted. It seems these cracks could possibly leak if they reach a significant size that may pose a serious health risk to the patient. The reported stress crack could result in leakage from the breathing system allowing the prescribed |
| Quantity | 900 units |
| Distribution | US Nationwide distribution including in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.