Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Reported: July 16, 2014 Initiated: June 17, 2014 #Z-2019-2014
Product Description
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Reason for Recall
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 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, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS). Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 1713 units.
Why was this product recalled? ▼
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2014. Severity: Moderate. Recall number: Z-2019-2014.
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