Z-0196-2014Class II

Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage...

Name: Z-0196-2014 Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-10-23
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-10-23 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial... on 2013-10-23. FDA classified it as Class II and gives the reason as "During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0196-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Posted: 2013-11-08
Terminated: 2014-07-18
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and Sarns" Venous Return Cannulae.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
Quantity in commerce: 40 units
Distribution: Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
Product codes and lots: Catalog Number 9473 Lot Numbers 0689812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0196-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08
Z-0194-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08
Z-0195-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08
Z-0196-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)