Bard—8 Fr Bardex Pediatric All-Silicone Foley Catheters: Valve Cap May Be Printed with Incorrect Inflation Volume

September 19, 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.

In a September 7, 2012, Urgent Product Recall Notification letter submitted by an ECRI Institute member hospital, Bard states that the valve cap of the catheters below may have been printed with an incorrect inflation volume (10 mL instead of the correct 5 mL). Bard also states that it has received no reports of patient injury or adverse events associated with this problem. The manufacturer has not confirmed the...

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