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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 Recall
StatLock Intravenous (IV) Catheter Stabilization Kit
see related information
Date Posted June 29, 2009
Recall Status1 Terminated on December 04, 2009
Recall Number Z-1539-2009
Recall Event ID 52046
Premarket Notification
510(K) Number
K980992 
Product Classification Set, Administration, Intravascular - 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, Georgia 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = VENETEC INTL., INC.
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