Reported Jun 6, 2018 · Terminated

Echogenic Needle; Product codes: PN-00215-E and PN-00217-E

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?

  • Echogenic Needle
  • Product codesPN-00215-E and PN-00217-E
Lot codes and dates
  • Lot NumbersProduct
  • Codes PN-00215-E13F17J0072 13F17K0211 13F17L0700
  • Product code PN-00217-E13F17C0329 13F17E0118 13F17F0503 13F17G0093 13F17G0534 13F17H0383 13F17L0234
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.

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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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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, 5:26 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.