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U.S. Department of Health and Human Services

Class 3 Device Recall Aspira Peritoneal Drainage system

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  Class 3 Device Recall Aspira Peritoneal Drainage system see related information
Date Initiated by Firm May 21, 2011
Date Posted August 08, 2011
Recall Status1 Terminated 3 on November 02, 2011
Recall Number Z-2962-2011
Recall Event ID 59119
510(K)Number K110396  
Product Classification Catheter, peritoneal, long-term indwelling - Product Code FJS
Product 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.
Code Information REUB0972, REUC0358, REUD0029, REUD0942, REVD0073.
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact
801-522-5614
Manufacturer Reason
for Recall		 Labeling for drainage kit contained incomplete information.
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 3275 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = FJS and Original Applicant = C.R. BARD, INC.
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