Arrow International Inc recalls Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

Recall date: April 11, 2018
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-2014-2018
FDA classification: Class II
Brand / firm: Arrow International Inc
Sold / distributed: US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWE…

Why it was recalled

Product sterility may be compromised due to unsealed packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

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