BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc.
- Company
- Becton Dickinson Medical Systems
- Recall Initiated
- October 19, 2009
- Posted
- February 2, 2010
- Terminated
- October 19, 2010
- Recall Number
- Z-0838-2010
- Quantity
- 4960 units
- Firm Location
- Sandy, UT
Reason for Recall
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Distribution
Nationwide distribution.
Lot / Code Info
Lot number: 8340302
Root Cause
Process control
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=