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U.S. Department of Health and Human Services

Class 2 Device Recall StatLock Intravenous (IV) Catheter Stabilization Kit

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  Class 2 Device Recall StatLock Intravenous (IV) Catheter Stabilization Kit see related information
Date Initiated by Firm April 02, 2009
Date Posted June 29, 2009
Recall Status1 Terminated 3 on December 04, 2009
Recall Number Z-1539-2009
Recall Event ID 52046
510(K)Number K980992  
Product Classification Intravascular Administration Set - Product Code FPA
Product Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
Code Information Lot #JUSJF441.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact Mary Mayo
770-784-6120
Manufacturer Reason
for Recall		 The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.
FDA Determined
Cause 2		 Process control
Action All consignees were notified by an Urgent: Product Recall Notification letter via Fed-Ex carrier on 04/02/2009. They were instructed not to use or further distribute any of the affected products. They were advised to check their inventory and to remove and return affected product to Bard Medical Division. A Recall & Effectiveness Check Form was included to be filled out and returned via fax, to Bard.
Quantity in Commerce 16,100 units
Distribution Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FPA and Original Applicant = VENETEC INTL., INC.
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