Recalls / —

—#92506

Product

Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846

FDA product code

DTR — Heat-Exchanger, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K823451

Affected lot / code info

Lot: MF03

Why it was recalled

Vent port may be occluded and prevent delivery of fluid

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern

Distribution USA and Canada

Timeline

Recall initiated

2010-06-08

Posted by FDA

2010-08-02

Terminated

2012-05-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #92506. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.