FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
- Recall number
- Z-0238-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
- Status
- Terminated
- Initiated
- 2006-09-14
- Posted
- 2006-12-07
- Terminated
- 2008-06-19
- Reason
- The hand crank handle may separate and detach from the unit during use.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
- Quantity
- 180
- Distribution
- Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 1126 through 1305.
- 510(k) numbers
- ["K915183"]
- 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