Recall Z-2962-2011 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
Bard Access Systems
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.
| Date | Aug 8, 2011 (initiated May 21, 2011) |
| Status | Terminated |
| Reason | Labeling for drainage kit contained incomplete information. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 3275 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110396 | ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. Bard, Inc., May 6, 2011 |