Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA device recall Z-0292-2007 · posted 2007-01-09 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Six inch roller pumps were mislabeled as 4 inch roller pumps.
- Action taken
- The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 2
- Distribution
- Worldwide-Michigan and Singapore.
- Date initiated
- 2005-10-06
- Date posted
- 2007-01-09
- Date terminated
- 2007-02-01
- 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 |