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U.S. Department of Health and Human Services

Class 1 Device Recall Closed IV Catheter system

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 Class 1 Device Recall Closed IV Catheter systemsee related information
Date Initiated by FirmOctober 19, 2009
Date PostedFebruary 02, 2010
Recall Status1 Terminated 3 on October 19, 2010
Recall NumberZ-0834-2010
Recall Event ID 53749
510(K)NumberK032843 
Product Classification Intravascular administration set. - Product Code FOZ
ProductBD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.
Code Information Lot number: 8248355, 8249034, 8249035, 8269338, 8270576, 8274565, 8275207, 8275210, 8283964, 8311167, 8312211, 8319016, 8347056, 9007360, 9015539, 9022039.
FEI Number 1710034
Recalling Firm/
Manufacturer		 Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
801-565-2341
Manufacturer Reason
for Recall		Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
FDA Determined
Cause 2		Process control
ActionConsignees 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 Commerce1,021,600 units
DistributionNationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FOZ
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