FDAnews Device Daily Bulletin

CDSCO of India Issues Recall for JMS Infusion Set

Dec. 14, 2016

The Central Drugs Standard Control Organization of India issued a field safety notice recalling an infusion set manufactured by Hemant Surgical Industries.

The product label indicates a shelf life of 61months, but CDSCO of India approved it for 3 years.

Users are to report the total quantity of the infusions systems received since Oct. 2013 and see if the infusion sets’ product labels read correctly for a shelf life of 3 years rather than 61 months. — Cynthia Jessup

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