Recall Z-1484-2014 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
| Date | Apr 25, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences. |
| Root cause | Software design |
| Action | On February 7, 2014, Baxter Healthcare Corporation distributed Urgent Device Correction notices and Customer Reply Forms to their customers via first-class mail. Affected customers are instructed to contact Baxter Healthcare Corporation at 1-800-356-3454 (choose option 1) Monday through Friday during the hours of 7:00 am to 7:00 pm Eastern Time. Baxter technicians would determine if an adjustment or repair is necessary. Customers are asked to complete the attached Customer Reply Form and return it to Baxter either by faxing to 1-224-270-5457 or e-mailing a scanned copy to fca@baxter.com. |
| Quantity | 277,096 units (revised) |
| Distribution | Worldwide Distribution - USA Nationwide including PR and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY Sigma Intl., Aug 26, 2004 |