FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
- Recall number
- Z-0659-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
- Status
- Terminated
- Initiated
- 2007-01-12
- Posted
- 2007-03-27
- Terminated
- 2008-06-19
- Reason
- The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- Root cause
- Other
- Action
- Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
- Quantity
- not on file
- Distribution
- Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
- Lot, serial or model codes
- Hand crank serial numbers 1621 and 1622.
- 510(k) numbers
- ["K900815"]
- PMA numbers
- not on file
- Product code
- DTW
- 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