IBC FloProbe (Non-sterile)…

Date posted by the FDA

July 12, 2006

Status

Terminated

Filed by

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.

Reason

Complaints received regarding the device's failure to zero out.

Distribution pattern

Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.

Quantity

7,502

Codes and lots

Lot #122004-100217 and #030805-100279.

Recall started

April 22, 2005

Device type

Probe, Blood-Flow, Extravascular

Root cause (FDA)

Other

What the company told customers

Firm notified customers via e-mail and phone calls starting on 04/22/05.

Recall number

Z-1223-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1223-06. The agency record governs; check it and the company before acting.