Reported Jun 6, 2018 · Terminated

Maximal Barrier Drape; Product Code: ASK-04000-HMC

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?

  • Maximal Barrier Drape
  • Product CodeASK-04000-HMC
Lot codes and dates
  • Lot Numbers13F17A0216 13F17D0073 13F17F0163 13F17G0522 13F17H0487 13F17L0121 13F17L0651
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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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, 5:27 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.