Reported Jun 6, 2018 · Terminated
Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 -…
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 ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters
- Product CodesMSO-29802-AHS and MSO-29903-AHS
- Lot codes and dates
- Lot NumbersProduct
- Code MSO-29802-AHS13F17C0408 13F17E0419 13F17F0683 13F17H0283 13F17K0545
- Product Code MSO-29903-AHS13F17E0607 13F17G0356 13F17K0327 13F17L0350
- 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.
Free recall alerts
Get alerted about new Arrow International Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.