Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
FDA device recall Z-2019-2014 · posted 2014-07-08 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
- Action taken
- 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
- Status
- Terminated
- Product code
- DTQ
- Quantity 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, O
- Date initiated
- 2014-06-17
- Date posted
- 2014-07-08
- Date terminated
- 2014-09-22
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947) | Terumo Cardiovascular Systems Corp. | 2003-03-20 |