BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.
FDA device recall Z-0834-2010 · posted 2010-02-02 · Terminated
Recall details
- Recalling firm
- Becton Dickinson Medical Systems
- Reason for recall
- Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Action taken
- 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=
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 1,021,600 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-10-19
- Date posted
- 2010-02-02
- Date terminated
- 2010-10-19
- Location
- Sandy, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXIVA CLOSED IV CATHETER SYSTEM (K032843) | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-02-27 |