Placentia, CA, United States
Bioseal Corporation recalls
2 recalls recorded since 2018, most recently on 23 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 23 March 2021
- Reason
- Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
- Distribution
- US: IL and MO OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1624-2021, Z-1622-2021, Z-1623-2021
- Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
- Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
- Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Terminated Class II Medical devices
- Recall started
- 15 August 2019
- Terminated
- 4 March 2021
- 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.
- Distribution
- US Nationwide distribution including in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2795-2020
- 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 con
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.