Reported Mar 27, 2024 · Ongoing
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF…
ARROW INTERNATIONAL Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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. · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
12 of 12 products
| Model / number | Product as published |
|---|---|
AK-04220 | — |
ASK-04220-FMH1 | — |
ASK-04220-HHC | — |
ASK-04220-KSP | — |
ASK-04220-PSU | — |
ASK-04220-UCL1 | — |
ASK-04500-AH | — |
ASK-04500-HF-S | — |
NA-04220-S1A | — |
NA-04220-X1A | — |
RA-04220 | — |
RA-04220-W | — |
- Amount recalled
- 1,160,470 devices
Where it was sold
Why it was recalled
Stop using this product now
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
Using this product could cause serious injury, illness or death — stop using it now.
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