Reported Jun 6, 2018 · Terminated

MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps…

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?

  • MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters
  • Product CodeASK-21242-NYP and ASK-21242-PR
Lot codes and dates
  • Lot NumbersProduct
  • code ASK-21242-NYP
    • 13F17A0076
    • 13F17B0076
    • 13F17B0225
    • 13F17E0773
    • 13F17H0129
    • 13F17J0020
    • 13F17J0395
    • 13F17L0012
  • Product code ASK-21242-PR13F17B0260 13F17F0591 13F17L0010 13F17L0273 13F17M0136
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, 4:44 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.