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U.S. Department of Health and Human Services

Class 2 Device Recall StatLock

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 Class 2 Recall
StatLock
see related information
Date Posted June 28, 2013
Recall Status1 Open
Recall Number Z-1618-2013
Recall Event ID 65202
Product Classification Device, Intravascular Catheter Securement - Product Code KMK
Product StatLock 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, Utah 84116-3738
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: Packaging
Action On 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 Commerce 3,875 units.
Distribution National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
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.
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