Recall Z-2655-2020— Carefusion 2200 Inc
Class II · Terminated
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2020-05-28, terminated 2024-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free. Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient..
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-28
- Terminated
- 2024-09-20
- Firm location
- Vernon Hills, IL, United States
Product description
Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
Reason for recall
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.