Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusio
FDA device recall Z-0295-2009 · posted 2008-11-07 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.
- Action taken
- U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008. For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 574
- Distribution
- Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines,
- Date initiated
- 2008-05-23
- Date posted
- 2008-11-07
- Date terminated
- 2009-08-04
- 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 |
|---|---|---|
| SARNS 9000 HEART-LUNG CONSOLE (K871131) | 3M Health Care, Sarns | 1987-05-21 |