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U.S. Department of Health and Human Services

Class 2 Device Recall SafeStep Huber Needle Set with YInjection Site

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  Class 2 Device Recall SafeStep Huber Needle Set with YInjection Site see related information
Date Initiated by Firm December 19, 2016
Date Posted January 10, 2017
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-0986-2017
Recall Event ID 76008
510(K)Number K040527  
Product Classification Set, administration, intravascular - Product Code FPA
Product SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton.

Product Usage:
Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
Code Information Lot Number: ASZKS076
Recalling Firm/
Manufacturer		 Bard Access Systems
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact Brenda Shelkey
800-290-1689
Manufacturer Reason
for Recall		 Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Bard sent an Urgent Notification letter dated December 16, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify and return affected product. For questions call 1-800-290-1689.
Quantity in Commerce 8000 units
Distribution Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.
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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = LUTHER NEEDLESAFE PRODUCTS, INC.
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