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Terminated

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.

FDA Recall Z-0676-2016 · Posted 2016-01-21

Recall StatusTerminated
Product CodeFPA
Date Initiated2016-01-05
Date Terminated2016-10-19
Product Quantity46,600 units

Reason for Recall

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

Firm 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: [email protected], 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: [email protected] or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: [email protected] or call 512-301-7338x309.

Root Cause

Process design

Distribution Pattern

US Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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