The U.S. Food and Drug Administration issued a recall of reprocessed Agilis Steerable Introducers from SterilMed, a unit of Johnson & Johnson, on product lots manufactured between January 1 and May 5, 2017. Agilis Introducer Sheaths reprocessed by AMDR member companies Innovative Health, Stryker Sustainability Solutions and Vanguard AG are NOT the subject of this recall and remain on the market.
Quality representatives from AMDR member companies have assured us that they are aware of the recall and that their strict quality control mechanisms, including 100 percent inspections, ensure that devices reprocessed by these companies continue to meet safety and efficacy expectations.
Our member companies are in full compliance with FDA’s medical device manufacturer requirements, meet FDA or international standards for quality systems and all have demonstrated such to AMDR as a condition of membership.
As with all other reprocessed devices, AMDR and its members urge hospitals to ensure their reprocessing partners have the right quality systems in place, possess the right level of sophistication in cleaning, testing and inspecting devices, and prioritize safety beyond anything else.
Read the full AMDR statement on the recall here.