FDA Device Recall Z-0023-04: Vital Concepts, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0023-04.

Recall Res Number

Z-0023-04

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

288

Product Description 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

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 50904954, 50905019 and 50905099.

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Medical Device Recall: Z-0023-04

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer