Reported Jun 6, 2018 · Terminated
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety…
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?
- Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters
- Product Codes
ASK-29803-SJHASK-29903-SJHand ASK-29903-UW1
- Lot codes and dates
- Lot NumbersProduct
- Codes ASK-29803-SJH13F17A0276 13F17D0104 13F17F0165 13F17G0452 13F17H0251 13F17K0284 13F17L0363
- Product code ASK-29903-SJH13F17C0105 13F17E0803 13F17G0422 13F17H0161 13F17H0204 13F17K0193 13F17M0197
- Product code ASK-29903-UW113F16L0231 13F17F0691
- Amount recalled
- 416,055 total products
This recall covers 76 products
The agency filed one notice per product. You are reading one of them; the other 75 are below.
63 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Product sterility may be compromised due to unsealed packaging.
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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