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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Convenience Kits

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 Class 2 Device Recall Centurion Convenience Kitssee related information
Date Initiated by FirmJanuary 19, 2016
Date PostedFebruary 23, 2016
Recall Status1 Terminated 3 on July 19, 2016
Recall NumberZ-0861-2016
Recall Event ID 73168
Product Classification Set, administration, intravascular - Product Code FPA
ProductConvenience 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 ContactLisa 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 2		Nonconforming Material/Component
ActionThe 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 Commerce1130
DistributionUS Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
Total Product Life CycleTPLC 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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