FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015-03 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
- Recall number
- Z-1531-2012
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015-03 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
- Status
- Terminated
- Initiated
- 2012-04-12
- Posted
- 2012-05-11
- Terminated
- 2013-01-23
- Reason
- Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Root cause
- Nonconforming Material/Component
- Action
- Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com
- Quantity
- 215 units
- Distribution
- Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
- Lot, serial or model codes
- Lot No: MD08 ; ME05 ; MF17; MH26; MK16; ML07
- 510(k) numbers
- ["K071494"]
- PMA numbers
- not on file
- Product code
- DTZ
- 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