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U.S. Department of Health and Human Services

Class 2 Device Recall StatLock IV Premium Catheter Stabilization Device

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  Class 2 Device Recall StatLock IV Premium Catheter Stabilization Device see related information
Date Initiated by Firm April 25, 2017
Date Posted May 19, 2017
Recall Status1 Terminated 3 on August 21, 2017
Recall Number Z-2120-2017
Recall Event ID 77132
Product Classification Device, intravascular catheter securement - Product Code KMK
Product StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
Code Information Lot Number JUAQF675, Exp 2/28/2019
Recalling Firm/
Manufacturer		 Bard Access Systems Inc.
605 N 5600 W
Salt Lake City UT 84116-3738
Manufacturer Reason
for Recall		 StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
FDA Determined
Cause 2		 Process control
Action Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.
Quantity in Commerce 4,500 units
Distribution Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
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.
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