Recall Z-2960-2011 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
Bard Access Systems
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.
| 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 | 21,040 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 |