Arrow International Inc recalls Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
- Recall date
- April 11, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1973-2018
- 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.
What was recalled
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
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