Company:SIGMA International, LLC
Date of Enforcement Report 6/18/12
Date Recall Initiated: July 6, 2011
Class l:
PRODUCT
SIGMA Spectrum Infusion Pump Model 35700. The SIGMA Spectrum Infusion Pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
REASON
Based on additional analyses since the initial recall, SIGMA expanded their recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the exception as noted above.
These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.
RECALLING FIRM/MANUFACTURER
SIGMA International, LLC, Medina, New York
FDA Comments:
On July 8, 2011, the company sent its customers an URGENT Medical Device Recall Notification letter dated July 6, 2011 by U.S. mail informing them of the expansion of the Spectrum Infusion Pumps recall. Some customers were notified by telephone.
Customers were instructed to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. Due to the possible failure of these units, SIMGA is taking the precautionary measure of servicing or replacing all affected Spectrum infusion pumps and is requiring the return of the recalled devices to its facility.
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