Recall Z-2018-2014 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
| Date | Jul 8, 2014 (initiated Jun 17, 2014) |
| Status | Terminated |
| Reason | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. |
| Root cause | Labeling Change Control |
| Action | 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) |
| Quantity | 1713 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp., Mar 20, 2003 |