Day

June 18, 2012
Company:SIGMA International, LLCDate 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....
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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