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U.S. Department of Health and Human Services

Class 2 Device Recall 1) Thoracentesis Tray; 2) SafeT Thoracentesis Tray

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  Class 2 Device Recall 1) Thoracentesis Tray; 2) SafeT Thoracentesis Tray see related information
Date Initiated by Firm August 28, 2013
Date Posting Updated September 11, 2013
Recall Status1 Terminated 3 on June 16, 2015
Recall Number Z-2193-2013
Recall Event ID 66123
Product Classification Needle, catheter - Product Code GCB
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.
Code Information res 7/31/14); L9K261 (Expires 9/30/14); L9P191 (Expires 12/31/14); L8K258 (Expires 8/31/13); L8L229 (Expires 9/30/13); L8S323 (Expires 12/31/13)
Recalling Firm/
Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact Ms. Mindy Faber
Manufacturer 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.
FDA Determined
Cause 2
Process change control
Action Recall notification letters dated 8/27/13 were distributed via courier to direct accounts. Consignees were/are requested to confirm receipt of the notification, examine their inventory for the recalled products and to destroy the products. After the products are destroyed, the consignees are requested to submit a completed response form to CareFusion for replacement with functional devices. Consignees who cannot destroy the affected products are requested to contact CareFusion for additional information.
Quantity in Commerce *** 1) 174,580 units; *** 2) 23,330 units
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MD, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and Puerto Rico, and the country of Iceland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.