FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, smooth balloon, manual-inflate. Catalog # 7270
- Recall number
- Z-1194-03
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, smooth balloon, manual-inflate. Catalog # 7270
- Status
- Terminated
- Initiated
- 2003-08-08
- Posted
- 2003-08-29
- Terminated
- 2004-03-11
- Reason
- Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Root cause
- Other
- Action
- Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo.
- Quantity
- not on file
- Distribution
- United States, Canada, Chile, China, Germany and Japan.
- Lot, serial or model codes
- Lots 1200560, 1205410, 1205420 and 1209760.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- 74DWF
- 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