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Terminated

Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

FDA Recall Z-0021-04 · Posted 2003-10-15

Recalling FirmVital Concepts, Inc.
Recall StatusTerminated
Product CodeGCY
Date Initiated2003-07-11
Date Terminated2004-04-12
Product Quantity2333

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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