Recall Z-2962-2011
Bard Access Systems · initiated May 21, 2011
Product
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.
Codes / lots: REUB0972, REUC0358, REUD0029, REUD0942, REVD0073.
Reason for recall
Labeling for drainage kit contained incomplete information.
FDA-determined 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.
Details
- Recall number
- Z-2962-2011
- Initiated
- May 21, 2011
- Posted by FDA
- August 8, 2011
- Terminated
- November 2, 2011
- Product code
- FJS – Catheter, Peritoneal, Long-Term Indwelling
- Quantity
- 3275 units
- Distribution
- Nationwide distribution.
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2959-2011 | Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |
| Z-2960-2011 | Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |
| Z-2961-2011 | Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |