FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5587.
- Recall number
- Z-1355-04
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5587.
- Status
- Terminated
- Initiated
- 2004-07-07
- Posted
- 2004-08-17
- Terminated
- 2004-10-26
- Reason
- The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Root cause
- Other
- Action
- The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.
- Quantity
- not on file
- Distribution
- United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWF
- 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