FDA Medical Device Recalls (openFDA)
International Biophysics Corp: 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.
- Recall number
- Z-1223-06
- 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.
- Status
- Terminated
- Initiated
- 2005-04-22
- Posted
- 2006-07-12
- Terminated
- 2006-07-18
- Reason
- Complaints received regarding the device's failure to zero out.
- Root cause
- Other
- Action
- Firm notified customers via e-mail and phone calls starting on 04/22/05.
- Quantity
- 7,502
- Distribution
- Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.
- Lot, serial or model codes
- Lot #122004-100217 and #030805-100279.
- 510(k) numbers
- ["K963703"]
- PMA numbers
- not on file
- Product code
- DPT
- Firm FEI
- 1000117854
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28