Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 900
FDA device recall Z-0532-2008 · posted 2008-01-24 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
- Action taken
- Consignees were notified of the defect/issue and what to do if it were to occur (short term work around) via an Urgent Medical Device Removal letter dated 9/14/07. As the permanent fix users were informed the sensor will be replaced when replacements become available.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KRL
- Quantity affected
- 175
- Distribution
- Worldwide: USA, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Equador, Germany, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Latin Amer
- Date initiated
- 2007-09-19
- Date posted
- 2008-01-24
- Date terminated
- 2009-07-07
- Location
- Ann Arbor, MI
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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 |