Z-0461-2009

CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use...

Name: Z-0461-2009 CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use...
Creator: CAS Medical Systems, Inc.
Published: 2008-09-20
License: https://open.fda.gov/license/

Cas Medical Systems, Inc. / initiated 2008-09-20 / Terminated / root cause: manufacturing process

FDA source

CAS Medical Systems, Inc. began a recall of CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and... on 2008-09-20. The reason FDA records is "Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0461-2009
Status: Terminated
Initiated: 2008-09-20
Posted: 2008-12-29
Terminated: 2010-08-05
Recalling firm: Cas Medical Systems, Inc.
Product: CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Product code: KZD Infusor, Pressure, For I.V. Bags
Reason for recall: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return and sub-recall be conducted to their accounts. The letter was entitled "UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE." For further information, please contact the firm at 203-488-6056.
Quantity in commerce: 5,576 pc.
Distribution: Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.
Product codes and lots: Lots: 21520608, 24710908, 29161308, 29171308, 31151308, 34471608, 2452208, and 43462308.

Product code KZD

K893519Class ITwin-Fusor/uni-Fusor Blood & Fluid Infusion CuffStatlabs, Inc. / cleared 1989-08-15

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)