RecallDepth

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.

Company
Vital Concepts, Inc.
Recall Initiated
July 11, 2003
Posted
October 15, 2003
Terminated
April 12, 2004
Recall Number
Z-0021-04
Quantity
2333
Firm Location
Grand Rapids, MI

Reason for Recall

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

Distribution

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

Lot / Code Info

lots 50904840, 50904918, 50904919, 50904935, 50904958, 50904959, 50904988, 50904994, 50905033, 50905050A, 50905093, 50905121 and 50905148.

Root Cause

Other

Action Taken

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

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