Class 2 Device Recall InVisionPlus CS Needleless IV Connector

• Date Initiated by Firm: January 05, 2016
• Date Posted: January 21, 2016
• Recall Status: Terminated on October 19, 2016
• Recall Number: Z-0676-2016
• Recall Event ID: 72997
• 510(K)Number: K093489
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
• Code Information: Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.
• Recalling Firm/ Manufacturer: Rymed Technologies, LLC; 6000 W William Cannon Dr Ste B300; Austin TX 78749-1991
• For Additional Information Contact: Anna McCutchen ; 512-301-7338
• Manufacturer Reason for Recall: Potential for the female luer component of the InVision-Plus IV connector to crack during use.
• FDA Determined Cause: Process design
• Action: The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIFICATION ASAP and no later than 10 business day via email to: amccutchen@rymedtech.com, fax to: 512-301-7338, Attention Recall Return Notification or mail to RyMed Technologies LLC, Attention Recall Return Notification, 6000 W. William Cannon, Building B, Suite 300 Austin, TX 78749. If you have any questions concerning the recall, contact Director of Quality Assurance/Regulatory Affairs by email to: amccutchen@rymedtech.com or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: svara@rymedtech.com or call 512-301-7338x309.
• Quantity in Commerce: 46,600 units
• Distribution: US Nationwide Distribution.
• 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