FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Corporation: Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010
- Recall number
- Z-2613-2010
- Recalling firm
- Terumo Cardiovascular Corporation
- Product
- Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010
- Status
- Terminated
- Initiated
- 2010-06-08
- Posted
- 2010-09-29
- Terminated
- 2012-02-29
- Reason
- Medical device vent port may be occluded and prevent delivery of priming fluid.
- Root cause
- Equipment maintenance
- Action
- Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.
- Quantity
- 160 kits
- Distribution
- The products were distributed nationwide.
- Lot, serial or model codes
- Lot Numbers: MD22, and ME19,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTR
- Firm FEI
- 3000204839
- Firm city
- Elkton
- Firm state
- MD
- 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