—#52656

Product

Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K063618
Affected lot / code info: Lot 2120273.

Why it was recalled

The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-05-22
Posted by FDA: 2007-07-10
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52656. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.