SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intraven
FDA device recall Z-0197-2014 · posted 2013-11-08 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
- Action taken
- On June 10, 2013 Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Library. The notices were dated June 5, 2013 and were distributed via first class mail. Until further information is provided, users should continue to follow the SIGMA SPECTRUM Infusion Pump Operator's Manual, which identifies a number of environmental and clinical usage factors that contribute to upstream occlusion and air-in-line alarms. For high-risk patients, consider having additional devices as backup. If the biomedical engineer finds that the sensor is not functioning properly, contact Baxter Healthcare at 800-356-3454 (choose option 1). For clinical questions, please contact Medical Information Services at Baxter at 800-933-0303, Monday through Friday 8:00am to 5:00 pm Central Time.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 273,835 units
- Distribution
- Worldwide Distribution-USA including Puerto Rico and Canada.
- Date initiated
- 2013-06-10
- Date posted
- 2013-11-08
- Date terminated
- 2017-04-20
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY (K042121) | Sigma Intl. | 2004-08-26 |