Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
FDA Recall Z-2018-2014 · Posted 2014-07-08
Advertisement
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2014-06-17
Date Terminated2014-09-22
Product Quantity1713 units
Reason for Recall
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
Firm 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)
Root Cause
Labeling Change Control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement