Recall Z-2018-2014— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2014-06-17, terminated 2014-09-22. It names one FDA 510(k) clearance: K022947. Product: Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS). Reason: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-17
- Terminated
- 2014-09-22
- Firm location
- Ann Arbor, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Terumo¿ Advanced Perfusion System 1 100/120V 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.