Class 2 Device Recall Centurion Convenience Kits

• Date Initiated by Firm: January 19, 2016
• Date Posted: February 23, 2016
• Recall Status: Terminated on July 19, 2016
• Recall Number: Z-0861-2016
• Recall Event ID: 73168
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Convenience Kits from Centurion that contain an In-Vision-; Plus Needleless IV Connector, Model: code RYM5001; ; InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
• Code Information: ECVC1010 CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017 ECVC1025 16CM CENTRAL LINE BUNDLE Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017 ECVC1425 20CM CENTRAL LINE BUNDLE Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017 ECVC1780 TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017 ECVC1785 QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017 ECVC3015 CVC TRIPLE LUMEN BUNDLE Batch Exp. 2015061050 01/2017 2015061850 01/2017 ECVC3260 CVC INSERT BUNDLE 16CM Batch Exp. 2015061150 09/2016 2015061550 09/2016 ECVC3540 TRIPLE LUMEN PI CVC BUNDLE Batch Exp. 2015041350 12/2016 ECVC3575 CVC TRIPLE LUMEN BUNDLE - 20CM Batch Exp. 2015041550 10/2016 2015061050 01/2017 ECVC3915 VANTEX TLC KIT: CURVED SUTURE NEEDLE Batch Exp. 2015040850 02/2017 2015042750 02/2017 2015070250 03/2017 2015081150 05/2017 ECVC3925 9F INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015071750 01/2017 ECVC405 CVC MULTI-LUMEN INSERTION BUNDLE Batch Exp. 2015041750 12/2016 2015061050 01/2017 ECVC4095 AVA HIGH FLOW BUNDLE Batch Exp. 2015060450 08/2016 ECVC4110 MULTI-MED TLC KIT: CURVED SUTURE NDL Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017 ECVC4115 6FR INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015080550 01/2017 ECVC4170 AVA 3xi CVC BUNDLE Batch Exp. 2015070250 06/2016
• Recalling Firm/ Manufacturer: Centurion Medical Products Corporation; 100 Centurion Way; Williamston MI 48895-9086
• For Additional Information Contact: Lisa A. Carpenter; 517-546-5400 Ext. 1156
• Manufacturer Reason for Recall: Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. A component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within these kits are not affected.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, RyMed Technologies, LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/4/2016 to the affected customers via certified mail on 1/19/2016 with instructions for identifying and returning the affected product. The recall letter included a description of the reason for the recall, affected product, actions to be taken, and instructions for responding to the formal recall notification. The customers were instructed to discontinue distribution and/or use and return product to: RyMed Technologies, LLC, 6000 W. William Cannon Drive, Building B, Suite 300, Austin, TX 78749; that user facilities change the IV connector within 24 hours when lipids are being administered; if you further distributed any of the lots, contact your accounts, advise them of recall and return their outstanding stock, complete and return enclosed Acknowledgement and Receipt Form ASAP and no later than 10 business days via E-mail: amccutchen@rymedtech.com, Fax: 512-301-7338 or by mail to address above, Attention Recall Return Notification. Please contact Director of Quality Assurance/Regulatory Affairs at (512) 301-7334 Ext.303 or email: ammccutchen@rymedtech.com should you have questions pertaining to recall notification. Questions pertaining to Returning Product/Replacement Product contact Logistics Specialist at (512) 301-7334 Ext.309 or email svara@rymedtech.com.
• Quantity in Commerce: 1130
• Distribution: US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
• 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.