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 | Risk Management News

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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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