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Terminated

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.

FDA Recall Z-2962-2011 · Posted 2011-08-08

Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeFJS
Date Initiated2011-05-21
Date Terminated2011-11-02
Product Quantity3275 units

Reason for Recall

Labeling for drainage kit contained incomplete information.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110396ASPIRA PERITONEAL DRAINAGE SYSTEMC.R. Bard, Inc. · 2011-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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