FDA Device Recall Z-0021-04: Vital Concepts, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-04.

Recall Res Number

Z-0021-04

Recalling Firm / Manufacturer

Vital Concepts, Inc.

FEI Number

1000115375

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-07-11

Date Posted

2003-10-15

Date Terminated

2004-04-12

Product Code

GCY

Event Number

27131

Product Quantity

2333

Product Description 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.

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

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

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

Code Information / Serial Numbers lots 50904840, 50904918, 50904919, 50904935, 50904958, 50904959, 50904988, 50904994, 50905033, 50905050A, 50905093, 50905121 and 50905148.

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Medical Device Recall: Z-0021-04

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer