Recall Z-2960-2011
Bard Access Systems · initiated May 21, 2011
Product
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.
Codes / lots: REUB0097, REUC0050, REUC0344, REUD0610, REUF0562, REUF0720, REUG1336, REUG1398, REUH1217, REUI0188, REUI0189, REUI1235, REUJ0357, REUJ0828, REUJ 0949, REUJ1275, REUK0657, REUK1351, REUL0589, REVA0241, REVA0884, REVB0093, REVB0619, REVC0073, REVC0419.
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-2960-2011
- Initiated
- May 21, 2011
- Posted by FDA
- August 8, 2011
- Terminated
- November 2, 2011
- Product code
- FJS – Catheter, Peritoneal, Long-Term Indwelling
- Quantity
- 21,040 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-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 |
| Z-2962-2011 | Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |