Recall Z-0146-2011 ยท FRN Pump, Infusion
Sigma International General Medical Apparatus, Llc
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 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. To be used in a healthcare facility in an IV pole mounte
| Date | Nov 5, 2010 (initiated Sep 15, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Urgent: Medical Device Recall Notification letters and forms (dated 9/14/10) were sent to the consignees via Certified Mail on/about 9/15/10. The letters inform the consignees of the recall of the pumps since these units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. Consignees are instructed to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. Due to possible bearing failure, SIGMA is taking the precautionary measure of servicing or replacing all affecte |
| Quantity | 17,557 Infusion Pumps |
| Distribution | Nationwide Distribution |
| 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 |