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Terminated

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.

FDA Recall Z-1223-06 · Posted 2006-07-12

Recalling FirmInternational Biophysics Corp
Recall StatusTerminated
Product CodeDPT
Date Initiated2005-04-22
Date Terminated2006-07-18
Product Quantity7,502

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963703ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)International Biophysics Corp. · 1998-04-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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