Reported May 16, 2018 · Terminated

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular…

Vygon U.S.A.

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: Vygon U.S.A. · 2750 Morris Rd Ste A200 · Lansdale, PA · 19446-6083

Is this the product you have?

  • Maximum Barrier Insertion Tray
  • Product CodeAMS-9152CP Convenience kit for the insertion of PICCs into the vascular system
Lot codes and dates
  • Lot Numbers17F001D & 17K038D
  • UDI08498840004814
Amount recalled
16520 total products

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

Potential friction holes may affect the sterility of the product.

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 Feb 19, 2019 · Data as of Sep 19, 6:15 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.