Reported Jun 6, 2018 · Terminated

Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018

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?

  • Spring-Wire Guide Introducer Catheter Assembly
  • Product CodeCN-04018
Lot codes and dates
  • Lot Numbers
    • 13F17B0039
    • 13F17C0181
    • 13F17D0226
    • 13F17E0065
    • 13F17E0724
    • 13F17F0651
    • 13F17G0531
    • 13F17H0377
    • 13F17J0273
    • 13F17L0216
    • 13F17L0218
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.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 15, 2020 · Data as of Sep 19, 5:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.