Z-0261-04

Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile...

Name: Z-0261-04 Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. 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 Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United... 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-0261-04
Status: Terminated
Initiated: 2003-11-07
Posted: 2004-07-20
Terminated: 2004-09-13
Recalling firm: Vital Concepts, Inc.
Product: Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
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: 3045
Distribution: Arizona, Illinois, Indiana, Michigan and Pennsylvania.
Product codes and lots: lots 50904937 and 50904995.

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)