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Terminated

RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.

FDA Recall Z-0321-2007 · Posted 2006-12-30

Recalling FirmRymed Technologies, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2006-05-25
Date Terminated2007-03-26
Product Quantity28,479 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.

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