FDA-Device2013-05-15Class I
Presource PBDS, Extremity, Kit, Circulator
Cardinal Health, Medical Products & Services
Hazard
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Sold states
Distributed in the states of AR, MS, SC, and TN.
Affected count
4,571 Kits total
Manufactured in
1430 Waukegan Road, Attn V. Mueller Qa, Park City, IL, United States
Products
Presource PBDS, Extremity, Kit, Circulator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2013Don't want to check this manually?
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