Z-0258-04

Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile...

Name: Z-0258-04 Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile...
Creator: Vital Concepts, Inc.
Published: 2003-11-07
License: https://open.fda.gov/license/

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

FDA source

Vital Concepts, Inc. began a recall of Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by... on 2003-11-07. The reason FDA records is "The probe may separate from the cannula". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0258-04
Status: Terminated
Initiated: 2003-11-07
Posted: 2004-07-20
Terminated: 2004-09-13
Recalling firm: Vital Concepts, Inc.
Product: Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
Product code: BYY Tube, Aspirating, Flexible, Connecting
Reason for recall: The probe may separate from the cannula.
FDA root cause: Other
Action: Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
Quantity in commerce: 86
Distribution: Arizona, Illinois, Indiana, Michigan and Pennsylvania.
Product codes and lots: lot 50904994.

Product code BYY

K934382Class IIVci Suction/irrigation Tubing SetVital Concepts, Inc. / cleared 1994-02-01

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)