Z-2961-2011

Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for...

Name: Z-2961-2011 Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for...
Creator: Bard Access Systems
Published: 2011-05-21
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2011-05-21 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic... on 2011-05-21. The reason FDA records is "Labeling for drainage kit contained incomplete information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2961-2011
Status: Terminated
Initiated: 2011-05-21
Posted: 2011-08-08
Terminated: 2011-11-02
Recalling firm: Bard Access Systems, Inc.
Product: Bard Aspira Luer Adapter, Product Code 4991505. 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.
Product code: FJS Catheter, Peritoneal, Long-Term Indwelling
Reason for recall: Labeling for drainage kit contained incomplete information.
Root cause tag: labeling and UDI
FDA root cause: 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: 4925 units
Distribution: Nationwide distribution.
Product codes and lots: REUB0099, REUC0051, REUD1012, REUI0191, REUI1181, REUK0310, REVA0246, REVB0890.

Product code FJS

K110396Class IIAspira Peritoneal Drainage SystemC.R. Bard, Inc. / cleared 2011-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)