FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
- Recall number
- Z-0617-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
- Status
- Terminated
- Initiated
- 2006-12-12
- Posted
- 2007-03-14
- Terminated
- 2008-06-19
- Reason
- Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
- Root cause
- Other
- Action
- Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.
- Quantity
- 2696
- Distribution
- Woldwide, including USA, Canada, and Mexico
- Lot, serial or model codes
- Serial numbers 0001 through 2696.
- 510(k) numbers
- ["K882758"]
- PMA numbers
- not on file
- Product code
- KFM
- 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