Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.

FDA Recall Z-0319-2007 · Posted 2006-12-30

Recalling FirmRymed Technologies, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2006-05-25
Date Terminated2007-03-26
Product Quantity34,849 units.

Reason for Recall

Weld failures on IV connector (area of female luer and spike body)

Firm Action

Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.

Root Cause

Other

Distribution Pattern

Nationwide Recall

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991653INVISION-PLUS INJECTION PORT CONNECTOR SYSTEMRymed Technologies, Inc. · 1999-06-24

Official Source

View FDA Recall →

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

↑