Reported Apr 18, 2018 · Terminated
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with…
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?
- Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr
- Catheters Part Number (PN)
ASK-29804-UHN2(2) For use with 7.5 - 8 Fr
- Catheters PNASK-29903-UCD
- Lot codes and dates
- Lot Numbers
(1) 13F17D018813F17E0570(2) 13F17E0660
- Lot Numbers
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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