Z-0833-2010

BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc

Name: Z-0833-2010 BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc
Creator: Becton Dickinson Medical Systems
Published: 2009-10-19
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2009-10-19 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson Medical Systems began a recall of BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc on 2009-10-19. The reason FDA records is "Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0833-2010
Status: Terminated
Initiated: 2009-10-19
Posted: 2010-02-02
Terminated: 2010-10-19
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Quantity in commerce: 8960 units
Distribution: Nationwide distribution.
Product codes and lots: Lot number: 8331763.

Product code FOZ

K032843Class IINexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. / cleared 2004-02-27

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)