CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Introducer Kit with Integral Hemostasis Valve/Side Port recalled
Arrow International is recalling Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and, distributed nationwide in the US. The recall was initiated on 9 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2329-2017
- FDA event ID
- 77232
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2017
- FDA classified
- 12 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 9 May 2017 | Recall initiated by company | |
| 12 Jun 2017 | Classified by FDA | +34 days |
| 21 Jun 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US (nationwide) and Canada
Questions about this recall
Is Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and recalled?
Yes. Arrow International recalled Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and on 9 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2329-2017.
Why was it recalled?
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which lots are affected?
Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883
Where was it sold?
Worldwide Distribution - US (nationwide) and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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