Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L
FDA device recall Z-1592-05 · posted 2005-09-28 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher
- Action taken
- Baxter sent the 8/17/05 Urgent Product Recall letter to all Baxter 6060E Infusion Pump customers to inform them of a software anomaly present in software versions 3.00 and higher, which allows the pump to overinfuse in the Auto-Ramp mode. The end users were also informed that these epidural pumps, identified by the yellow housing, can no longer be supported due to a lack of availability of spare parts and Baxter is unable to replace the software with an alternate version. As a result, Baxter requested the accounts to remove the pumps from service and return them to Baxter. The accounts were requested to call Baxter''s Medication Delivery Services at 1-800-843-7867 to arrange for the return of the units and replacement with 6060 Multi-Therapy Infusion Pumps.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Distribution
- Nationwide including Puerto Rico, and intenationally to Canada, China, Belgium, Hong Kong and Saudi Arabia
- Date initiated
- 2005-08-17
- Date posted
- 2005-09-28
- Date terminated
- 2007-06-19
- 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 |
| SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP (K941984) | Sabratek Corp. | 1994-07-19 |