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Class 3 Device Recall Aspira Peritoneal Drainage system |
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Date Initiated by Firm |
May 21, 2011 |
Date Posted |
August 08, 2011 |
Recall Status1 |
Terminated 3 on November 02, 2011 |
Recall Number |
Z-2960-2011 |
Recall Event ID |
59119 |
510(K)Number |
K110396
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Product Classification |
Catheter, peritoneal, long-term indwelling - Product Code FJS
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Bard Access Systems 605 North 5600 West Salt Lake City UT 84116-3738
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For Additional Information Contact |
801-522-5614
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Manufacturer Reason for Recall |
Labeling for drainage kit contained incomplete information.
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FDA Determined Cause 2 |
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 in Commerce |
21,040 units |
Distribution |
Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FJS and Original Applicant = C.R. BARD, INC.
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