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U.S. Department of Health and Human Services

Class 2 Device Recall StatLock CV Plus w/Pigtail

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 Class 2 Device Recall StatLock CV Plus w/Pigtailsee related information
Date Initiated by FirmDecember 09, 2016
Date PostedJanuary 10, 2017
Recall Status1 Terminated 3 on May 26, 2017
Recall NumberZ-0982-2017
Recall Event ID 75908
Product Classification Device, intravascular catheter securement - Product Code KMK
ProductStatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Code Information Lot Number: JUZKF615 & JUAPF369.
Recalling Firm/
Manufacturer		 Bard Access Systems
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information ContactBrenda Shelkey
801-595-0700
Manufacturer Reason
for Recall		Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
FDA Determined
Cause 2		Process design
ActionBard sent an Urgent Customer Notification letter dated December 12, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and identify any product subject to the notification. Please direct any return requests and/or questions to Shelly Gilbert at 1-800-290-1689.
Quantity in Commerce14,500 units total
DistributionWorldwide Distribution - US Nationwide
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.
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