Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., D
FDA device recall Z-0376-04 · posted 2004-01-29 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Premature motor failure.
- Action taken
- Baxter sent letters dated 12/17/03 to all Baxter 6060 Multi-Therapy Infusion Pump accounts that received pumps manufactured with the affected motors or who had their pumps refurbished with affected motors. The letters included a list of affected pump serial numbers for each facility. The accounts were informed of the possible premature motor failure, and were requested to contact Baxter via fax to schedule a service call to correct the pumps.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 188 units
- Distribution
- The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan.
- Date initiated
- 2003-12-17
- Date posted
- 2004-01-29
- Date terminated
- 2006-11-28
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 (K002679) | Baxter Healthcare Corp | 2000-09-18 |