Z-0200-06

Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5...

Name: Z-0200-06 Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5...
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-09-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-09-12 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of 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... on 2005-09-12. The reason FDA records is "There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0200-06
Status: Terminated
Initiated: 2005-09-12
Posted: 2005-11-26
Terminated: 2006-03-22
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
FDA 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 in commerce: 2520
Distribution: Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.
Product codes and lots: Lots 0385384 and 0386969.

Product code DWF

K771499Class IIFlexible Arterial Cannulae3M Health Care, Sarns / cleared 1977-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)