Z-0022-04

HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use...

Name: Z-0022-04 HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use...
Creator: Vital Concepts, Inc.
Published: 2003-07-11
License: https://open.fda.gov/license/

Vital Concepts, Inc. / initiated 2003-07-11 / Terminated

FDA source

Vital Concepts, Inc. began a recall of HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital... on 2003-07-11. The reason FDA records is "The suction valve may become stuck in the 'suction on' position under vacuum". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0022-04
Status: Terminated
Initiated: 2003-07-11
Posted: 2003-10-15
Terminated: 2004-04-12
Recalling firm: Vital Concepts, Inc.
Product: HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: The suction valve may become stuck in the 'suction on' position under vacuum.
FDA root cause: Other
Action: A request for product return was sent to each customer beginning on July 11, 2003.
Quantity in commerce: 196
Distribution: Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
Product codes and lots: lots 50904972 and 50905039.

Product code GCY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)