Baxter—Various Non-DEHP Catheter Extension Sets and Set Kits: Package May Be Inadvertently Opened, Potentially Leading to Compromised Sterility

April 10, 2013 | 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.

In a March 28, 2013, Urgent Product Recall letter submitted by an ECRI Institute member hospital, Baxter states that the packaging containing the above products may be inadvertently opened, potentially leading to compromised sterility. Baxter states that this problem poses a patient risk of blood infection and bacteremia. The problem may occur when an individual package, distributed in strips separated by perforations, is separated from its attached grouping and an adjacent package is inadvertently opened. Baxter indicates that the root cause of this problem has been identified and resolved, and that this problem does not affect all lots of the above products. The manufacturer has not confirmed the...

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