—#49920

Product

Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K930620
Affected lot / code info: Lot 2119905, exp. October 2009.

Why it was recalled

The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".

Root cause (FDA determination)

Other

Action the firm took

Consignee was notified via telephone on 12/7/06 and returned the product.

Recalling firm

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

Distribution

Distribution pattern: Pennsylvania.

Timeline

Recall initiated: 2006-12-07
Posted by FDA: 2007-02-27
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.