Reported Jul 21, 2021 · Ongoing
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK -…
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr
- introducer Product CodeAI-07155-IK -
- Product Usageintended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
- Lot codes and dates
- Lot Numbers23F20A0230 23F20E0004 23F20E0094
- Amount recalled
- 15 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Marketed without a 510K
This product could cause temporary or reversible health problems — stop using it.
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