InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for sin

FDA device recall Z-0676-2016 · posted 2016-01-21 · Terminated

Recall details

Recalling firm

Rymed Technologies, LLC

Reason for recall

Potential for the female luer component of the InVision-Plus IV connector to crack during use.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

FPA

Quantity affected

46,600 units

Distribution

US Nationwide Distribution.

Date initiated

2016-01-05

Date posted

2016-01-21

Date terminated

2016-10-19

Location

Austin, TX

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