Recall Z-2193-2013— Carefusion 2200 Inc
Class II · Terminated
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2013-08-28, terminated 2015-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.. Reason: Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications..
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-28
- Terminated
- 2015-06-16
- Firm location
- Vernon Hills, IL, United States
Product description
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.
Reason for recall
Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.