FDA Announces Recall of Stryker Neptune 1 (Silver) and Neptune 2 (Ultra) Waste Management Systems Because Devices Do Not Have 510(k) Clearance

October 10, 2012 | Strategic Insights for Health System


ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

As reported in Special Report Accession No. S0230, Stryker states that FDA has advised them that the below-listed waste management systems require but do not have 510(k) clearance; FDA is unable to determine whether the above waste management systems are as safe and effective as the previous version, Neptune 1 (Gold). The Neptune 1 (Gold) and Neptune 1...

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