Bard Aspira Dressing Kit, Product Code 4991503. 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.
Recall
- Recall Number
- Z-2960-2011
- Event Number
- 59119
- Firm
- Bard Access Systems
- FEI Number
- 3006260740
- Product Code
- FJS
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 21, 2011
- Posted
- August 8, 2011
- Terminated
- November 2, 2011
- Address
- 605 North 5600, West Salt Lake City, UT, 84116-3738
Description
Bard Aspira Dressing Kit, Product Code 4991503. 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.
Labeling for drainage kit contained incomplete information.
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.
Nationwide distribution.
21,040 units