—#108803

Product

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071494
Affected lot / code info: Lot No: MH06

Why it was recalled

Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.

Timeline

Recall initiated: 2012-04-12
Posted by FDA: 2012-05-11
Terminated: 2013-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108803. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.