Medline—Custom Kits Containing Avanos BALLARD 1500 Flex Heat-Moisture Exchangers: May Disconnect from Closed Respiratory Circuit, Potentially Leading to Hypoxia or Death

October 21, 2020 | Strategic Insights for Health System

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​ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In an October 1, 2020, Subrecall Immediate Action Required letter submitted by an ECRI member hospital, Medline states that the above kits contain HMEs recalled by Avanos because they may disconnect from the closed respiratory circuit during use, potentially resulting in a lack of oxygen leading to hypoxia or death. Medline also states that Avanos has received six reports of this problem but no reports of injuries or adverse events. The manufacturer has not confirmed the...

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