Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300.
FDA device recall Z-0235-2007 · posted 2006-12-07 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The hand crank handle may separate and detach from the unit during use.
- Action taken
- Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTW
- Quantity affected
- 61
- Distribution
- Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa,
- Date initiated
- 2006-09-14
- Date posted
- 2006-12-07
- 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 |