FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
- Recall number
- Z-2550-2018
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
- Status
- Terminated
- Initiated
- 2017-05-12
- Posted
- not on file
- Terminated
- 2018-10-26
- Reason
- Kit was labeled with the incorrect Expiration Date of April 30, 2019.
- Root cause
- Incorrect or no expiration date
- Action
- On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
- Quantity
- 30 cases/2 units (Total 60 units)
- Distribution
- US state of FL
- Lot, serial or model codes
- Lot Number: VE17
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- Firm FEI
- 1000149028
- Firm city
- Ashland
- Firm state
- MA
- 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