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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 systemsee related information
Date Initiated by FirmMay 21, 2011
Date PostedAugust 08, 2011
Recall Status1 Terminated 3 on November 02, 2011
Recall NumberZ-2960-2011
Recall Event ID 59119
510(K)NumberK110396 
Product Classification Catheter, peritoneal, long-term indwelling - Product Code FJS
ProductBard 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
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
ActionThe 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 Commerce21,040 units
DistributionNationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FJS
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