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U.S. Department of Health and Human Services

Class 2 Device Recall StatLock

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 Class 2 Device Recall StatLocksee related information
Date Initiated by FirmJune 10, 2013
Date PostedJune 28, 2013
Recall Status1 Terminated 3 on May 21, 2014
Recall NumberZ-1618-2013
Recall Event ID 65202
Product Classification Device, intravascular catheter securement - Product Code KMK
ProductStatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.
Code Information Lot JUWJF283
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet
FDA Determined
Cause 2		Packaging
ActionOn 6/18/13, an "Urgent Kit Recall" notification letter was mailed to all customers informing them of the recall and instructing the consignee to remove and return any affected product lot numbers to Bard Access Systems through return goods authorization. Customers may contact 800-290-1689 if questions.
Quantity in Commerce3,875 units.
DistributionNational and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
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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