Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
1) Introducer Kit with Integral Hemostasis Valve/Side Port Recalled by Arrow International Inc Due to Arrow International is recalling the affected product because...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected 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
Quantity: 27,485 units distributed in U.S, 4,371 units distributed internationally
Why Was This Recalled?
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report