—#41973

Product

Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K771499
Affected lot / code info: Lots 0385384 and 0386969.

Why it was recalled

There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

Root cause (FDA determination)

Other

Action the firm took

Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.

Timeline

Recall initiated: 2005-09-12
Posted by FDA: 2005-11-26
Terminated: 2006-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41973. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.