FDA-Device2017-06-21Class II
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Arrow International Inc
Hazard
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Sold states
Worldwide Distribution - US (nationwide) and Canada
Affected count
27,485 units distributed in U.S, 4,371 units distributed internationally
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2017Don't want to check this manually?
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