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Terminated

HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

FDA Recall Z-0023-04 · Posted 2003-10-15

Recalling FirmVital Concepts, Inc.
Recall StatusTerminated
Product CodeGCY
Date Initiated2003-07-11
Date Terminated2004-04-12
Product Quantity288

Reason for Recall

The suction valve may become stuck in the 'suction on' position under vacuum.

Firm Action

A request for product return was sent to each customer beginning on July 11, 2003.

Root Cause

Other

Distribution Pattern

Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960616VITAFLOW SUCTION/ASPIRATION TUBING SETVital Concepts, Inc. · 1996-05-06K934382VCI SUCTION/IRRIGATION TUBING SETVital Concepts, Inc. · 1994-02-01

Official Source

View FDA Recall →

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

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