FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
- Recall number
- Z-0200-06
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
- Status
- Terminated
- Initiated
- 2005-09-12
- Posted
- 2005-11-26
- Terminated
- 2006-03-22
- Reason
- There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
- Root cause
- Other
- Action
- Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.
- Quantity
- 2520
- Distribution
- Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.
- Lot, serial or model codes
- Lots 0385384 and 0386969.
- 510(k) numbers
- ["K771499"]
- 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