Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion Syst
FDA device recall Z-0301-2012 · posted 2011-11-29 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed
- Action taken
- Terumo sent an URGENT MEDICAL DEVICE REMOVAL notification letter dated November 10, 2011 to all affected customers. The letter described the affected products, problem, potential hazards, and important clinical information. Replacement roller pumps will be configured at the customer site by a Terumo Field representative with the affected roller pumps being returned via normal returned goods process. Customers were asked to complete the attached response form and fax to the number indicated on the form. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 5 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
- Date initiated
- 2011-11-10
- Date posted
- 2011-11-29
- Date terminated
- 2012-09-06
- 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 |