FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
- Recall number
- Z-0293-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
- Status
- Terminated
- Initiated
- 2005-10-06
- Posted
- 2007-01-09
- Terminated
- 2007-02-01
- Reason
- An incorrect serial number was placed on one roller pump.
- Root cause
- Other
- Action
- The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
- Quantity
- 1
- Distribution
- Worldwide-Michigan and Singapore.
- Lot, serial or model codes
- Serial number 0391(correct) was labeled as serial number 3091 (incorrect).
- 510(k) numbers
- ["K022947"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- 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