FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.
- Recall number
- Z-0879-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.
- Status
- Terminated
- Initiated
- 2007-05-22
- Posted
- 2007-07-10
- Terminated
- 2009-07-07
- Reason
- The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- Root cause
- Other
- Action
- Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.
- Quantity
- 92
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 2120267.
- 510(k) numbers
- ["K063618"]
- 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