Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Pl

FDA device recall Z-0861-2016 · posted 2016-02-23 · Terminated

Recall details

Recalling firm

Centurion Medical Products Corporation

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FPA

Quantity affected

1130

Distribution

US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.

Date initiated

2016-01-19

Date posted

2016-02-23

Date terminated

2016-07-19

Location

Williamston, MI