—#42795

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.

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: All lots (0332197, 0349597, 0360492, 0369078, 0373045, 0382401, 0391806 and 0399838).

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: California, Indiana, Missouri, Brazil and Germany.

Timeline

Recall initiated: 2005-10-19
Posted by FDA: 2005-11-23
Terminated: 2006-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.