BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall Z-0837-2010 · Posted 2010-02-02
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Recalling FirmBecton Dickinson Medical Systems
Recall StatusTerminated
Product CodeFOZ
Date Initiated2009-10-19
Date Terminated2010-10-19
Product Quantity303,280 units
Reason for Recall
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Firm 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=
Root Cause
Process control
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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