Z-0181-06

Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD...

Name: Z-0181-06 Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD...
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-10-19
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-10-19 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long... on 2005-10-19. The reason FDA records is "The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0181-06
Status: Terminated
Initiated: 2005-10-19
Posted: 2005-11-23
Terminated: 2006-03-10
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via telephone, and a recall letter dated 10/19/05 sent to each consignee, beginning on 10/18/05. International affiliates were notified via email.
Quantity in commerce: 48
Distribution: California, Indiana, Missouri, Brazil and Germany.
Product codes and lots: All lots (0332197, 0349597, 0360492, 0369078, 0373045, 0382401, 0391806 and 0399838).

Product code DWF

K934127Class IISarns Low Jetting Aortic Arch Cannula3M Health Care, Sarns / cleared 1994-02-22

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)