Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
This recall has been terminated (originally issued August 8, 2011).
- Company
- Bard Access Systems
- Recall Initiated
- May 21, 2011
- Posted
- August 8, 2011
- Terminated
- November 2, 2011
- Recall Number
- Z-2962-2011
- Quantity
- 3275 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling for drainage kit contained incomplete information.
Distribution
Nationwide distribution.
Lot / Code Info
REUB0972, REUC0358, REUD0029, REUD0942, REVD0073.
Root Cause
Error in labeling
Action Taken
The firm, BARD, sent a letter entitled "Labeling Discrepancy on Aspira Drainage Accessory Kits" dated June 12, 2011 to its customers. The letter provides the customers with the information missing from the labeling and/or IFU stating that the product can be safely used for peritoneal and pleural applications. If you have any questions please do not hesitate to contact BARD at 1-800-290-1689. If there are any clinical questions please contact Medical Services and Support at 1-866-893-2691.
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