Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for inte
FDA device recall Z-2962-2011 · posted 2011-08-08 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Labeling for drainage kit contained incomplete information.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- FJS
- Quantity affected
- 3275 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-05-21
- Date posted
- 2011-08-08
- Date terminated
- 2011-11-02
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASPIRA PERITONEAL DRAINAGE SYSTEM (K110396) | C.R. Bard, Inc. | 2011-05-06 |