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
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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