—#122797

Product

Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K934127
Affected lot / code info: Catalog Number 5798 Lot Numbers 0677301

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.

Timeline

Recall initiated: 2013-10-23
Posted by FDA: 2013-11-08
Terminated: 2014-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.