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
Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2329-2017
Product Description
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
Reason for Recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 27,485 units distributed in U.S, 4,371 units distributed internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Arrow International Inc. Units affected: 27,485 units distributed in U.S, 4,371 units distributed internationally.
Why was this product recalled? ▼
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2329-2017.
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