Recall: Physio-Control Inc., issued an URGENT Medical Device Recall: Due to Artwork Depicts Incorrect Electrode Placement for Infants
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1 USAF Dental Evaluation & Consultation Service Recall: Physio-Control Inc., issued an URGENT Medical Device Recall: Due to Artwork Depicts Incorrect Electrode Placement for Infants This recall is being initiated by Physio-Control Inc., on specific production lots of Infant Child Reduced Energy Defibrillation Electrodes produced by Cardinal Health. Approximately 14,200 electrodes have been effected. The defibrillation electrodes are used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AEDs. CLICK HERE for the entire recall notice and instructions for identifying affected products/lot numbers and additional instructions from Physio-Control Inc.
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3 Physio-Control, Inc. I Lifesaving starts here. Physic-Control's Planned Actions Physic-Control will provide replacement products for all unused affected electrodes. Following are the affected lots: Description Catalog# MIN# Lot Number Electrode Electrode Starter Kits Confirm the quantity of the affected lot numbers listed above in your inventory. You may identify the Catalog and Lot Number by looking at the labels on the outside of the electrode pouch, electrode box, or electrode starter kit box following the information below. ti (01) Electrode Pouch and Box Labeling (11)YYMMOO (17)YYMMDD (IO)XXXXJ<.. Electrode Starter Kit Box Labelin (11JYYMM00(17JYYMM00(10JXXXXXX I PMX.XXXX CH4WO()(XXX JIIIIIIIJIIUIIIIIIIIIIIUEIIDlllllllDID t01)(0121m21uu.xfll)wi.m?qfjl'l)'t'l'w.ciotuj:lljt You may contact Physic-Control at , 6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday to arrange for replacement of your unused electrodes. In addition to contacting Physic-Control, any potential quality problems or adverse reactions or events associated with the use of a Physic-Control product may be reported to the U.S. Food and Drug Administration's MedWatch Safety Information and Adverse Event Reporting Program online at by phone or fax FDA We apologize for this inconvenience. Should you have any questions about this Product Recall, please contact us at , 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday. Sincerely, f{ c:. Kathryn E. Janecke Senior Director, Quality Physic-Control, Inc.
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6 Safety Alerts for Human Medical Products > Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork... Search FDA Home Safety MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork on Packaging SHARE TWEET LINKEDIN PIN IT PRINT Electrodes used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector [Posted 11/06/2017] AUDIENCE: Risk Manager, Emergency Medicine ISSUE: Physio-Control announced it is launching a voluntary field action for specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health. The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death. BACKGROUND: The defibrillation electrodes are used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Adult defibrillation electrodes are not impacted. Approximately 14,200 electrodes have been affected. RECOMMENDATION: Affected customers will be notified by letter. The company is contacting customers to notify them of the issue, and to provide customers with correct electrode placement instructions to be included with the AEDs until they receive their corrected defibrillation electrodes. Physio-Control will provide 2:15:58 PM]
7 Safety Alerts for Human Medical Products > Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork... replacement products for all unused affected defibrillation electrodes. As an alternative, if customers decide not to use the affected defibrillation electrodes and they do not have a spare set of infant/child defibrillation electrodes, based on American Heart Association (AHA) and European Resuscitation Council (ERC) 2015 Guidelines, customers may consider the use of adult defibrillation electrodes until they receive their replacement set of infant/child defibrillation electrodes. Information is available at: Customers with questions regarding this notification should contact Physio-Control by calling , 6:00 a.m. to 4:00 p.m. (Pacific) Monday Friday, or by to rsrecalls@physio-control.com or fax to Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: Download form or call to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to FDA-0178 [10/27/ Press Release - Physio-Control] More in Safety Alerts for Human Medical Products 2017 Safety Alerts for Human Medical Products 2016 Safety Alerts for Human Medical Products Page Last Updated: 11/06/2017 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español Ti ng Vi t Tagalog Kreyòl Ayisyen Français Polski Português Italiano Deutsch English Accessibility Careers FDA Basics FOIA No FEAR Act Site Map Nondiscrimination Website Policies U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD INFO-FDA ( ) Contact FDA 2:15:58 PM]
8 Safety Alerts for Human Medical Products > Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork... FDA Archive Emergency Preparedness Federal, State & Local Officials Combination Products International Programs Consumers Advisory Committees News & Events Health Professionals Regulatory Information Training & Continuing Education Science & Research Safety Inspections & Compliance Industry 2:15:58 PM]
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POL:08:LP:003:03:NIBT PAGE : 1 of 5. Document Title: NIBTS POLICY FOR RETURN AND RE-ISSUE OF BLOOD AND BLOOD COMPONENTS
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This document is scheduled to be published in the Federal Register on 02/26/2018 and available online at https://federalregister.gov/d/2018-03809, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN