FDA Medical Device Recalls (openFDA)
Becton Dickinson Medical Systems: BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
- Recall number
- Z-0833-2010
- Recalling firm
- Becton Dickinson Medical Systems
- Product
- BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
- Status
- Terminated
- Initiated
- 2009-10-19
- Posted
- 2010-02-02
- Terminated
- 2010-10-19
- Reason
- Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- 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
- 8960 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Lot number: 8331763.
- 510(k) numbers
- ["K032843"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1710034
- Firm city
- Sandy
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28