FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Sarns MP4 Cardioplegia Sets; catalog number 15501.
- Recall number
- Z-0664-03
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Sarns MP4 Cardioplegia Sets; catalog number 15501.
- Status
- Terminated
- Initiated
- 2003-02-25
- Posted
- 2003-03-20
- Terminated
- 2003-06-06
- Reason
- There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
- Root cause
- Other
- Action
- Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.
- Quantity
- 300
- Distribution
- United States
- Lot, serial or model codes
- Lot 322125
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTR
- 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