—#127207

Product

Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Catalog Number 801764

Why it was recalled

An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

On June 17, 2014, TCVS sent URGENT MEDICAL DEVICE RECALL notification to consignees. Notification included reason for recall, potential hazard, correction, affected population, and customer instructions. Questions concerning the recall are directed to Terumo CVS Customer Service @ 800-521-2818 (M-F, 8am-6pm)

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.

Timeline

Recall initiated: 2014-06-17
Posted by FDA: 2014-07-08
Terminated: 2014-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.