Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
FDA device recall Z-0655-2007 · posted 2007-03-27 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- Action taken
- Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTW
- Quantity affected
- 7
- Distribution
- Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
- Date initiated
- 2007-01-12
- Date posted
- 2007-03-27
- Date terminated
- 2008-06-19
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815) | 3M Company | 1990-05-09 |