Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced Perfusion System 1
FDA device recall Z-0310-2009 · posted 2008-11-25 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The pumps may fail to power up or experience unplanned pump stops.
- Action taken
- Consignees were advised of the problem via an Urgent Medical Device Correction: Safety Advisory letter dated 7/18/08 and each consignee was contacted by phone to assure receipt. The letter noted that the firm was not recommending that customers stop using the product. If customers found the risk unacceptable they were to contact Technical Service, 1-800-521-2818. Customers were to review the notice, assure all users were aware of the notice, and confirm receipt by completing the attached Customer Response Form and faxing it to the number indicated on the form.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 1429
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philip
- Date initiated
- 2008-07-18
- Date posted
- 2008-11-25
- 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 |