Recall Z-1490-2012 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical d
| Date | Jun 13, 2012 (initiated Jul 6, 2011) |
| Status | Terminated |
| Reason | Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to |
| Root cause | Nonconforming Material/Component |
| Action | Sigma sent an URGENT Medical Device Recall Notifications letter dated July 6, 2011 via UPS mail the consignees informing them of the expansion of the Spectrum Infusion Pumps recall. Some consignees were notified by telephone. The letter identified the affected product, problem, actions to be taken, clinical precautions and recommendations. Additional information regarding this voluntary recall is available on Sigma's web site www.sigmapumps.com/Recall. Customers were provided the following instructions: (1) Confirm that you have the affected serial number(s) ranging from 700000 to 794213 i |
| Quantity | 63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps |
| Distribution | Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa |
| 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 |