Reported Apr 18, 2018 · Terminated
(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal…
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?
7 of 7 products
| Model / number | Product as published |
|---|---|
ASK-09803-WBH1 | (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters |
ASK-09903-KH | (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters |
ASK-09903-LC | (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters |
ASK-09903-PHP | (4) PSI Kit for use with 7.5 - 8 Fr. Catheters |
ASK-09907-LGH1 | (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters |
CDC-09803-1A | (6) Arrow PSI Kit |
CDC-09903-1A | (7) Arrow PSI Kit |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 (1) 13F17C0208, 13F17F0162 2 (2) 13F17F0231 3 (3) 13F17E0382, 13F17F0206 4 (4) 13F17D0049 5 (5) 13F17A0052, 13F17C0390 6 (6) 13F17A0123, 13F17E0014, 13F17E0455, 13F17F0289 7 (7) 13F16M0274, 13F17E0040, 13F17E0227, 13F17E0824
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.
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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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