Z-1223-06

IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console...

Name: Z-1223-06 IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console...
Creator: International Biophysics Corp
Published: 2005-04-22
License: https://open.fda.gov/license/

International Biophysics Corp. / initiated 2005-04-22 / Terminated

FDA source

International Biophysics Corp began a recall of IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is... on 2005-04-22. The reason FDA records is "Complaints received regarding the device's failure to zero out". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1223-06
Status: Terminated
Initiated: 2005-04-22
Posted: 2006-07-12
Terminated: 2006-07-18
Recalling firm: International Biophysics Corp.
Product: IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.
Product code: DPT Probe, Blood-Flow, Extravascular
Reason for recall: Complaints received regarding the device's failure to zero out.
FDA root cause: Other
Action: Firm notified customers via e-mail and phone calls starting on 04/22/05.
Quantity in commerce: 7,502
Distribution: Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.
Product codes and lots: Lot #122004-100217 and #030805-100279.

Product code DPT

K963703Class IIAccuflo Monitoring System (1800)/ Accuflo Probe (8000)International Biophysics Corp. / cleared 1998-04-08

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)