Reported Feb 12, 2020 · Terminated

AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515

Cardinal Health

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: Cardinal Health · 1350 Bridge Dr · Waukegan, IL · 60085-6306

Is this the product you have?

    • AAMI 3 NON-REINF SURG GOWN LG 2 TWL
    • Item Code ASG9515
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
1Lot Format: YYMRJXXX Where: YY Last two digits of the year ( 18 or '19) M Month in alpha code " If made in 2018 o J for September o K for October o L for November OR o M for December " If made in 2019, any value is affected R Product revision or suffix P Facility code is letter J XXX Sequential Number - Monthly reset OR Bulk Non-Sterile
2Lot Format: XXXYRPQ Where: XXX Elapsed days of year " " If made in 2018, 244 or greater is affected OR " " If made in 2019, any value is affected; see below for year made identifier Y Last character of year gown was made (2018 or 2019) R Product Revision P Facility code is letter J Q Plant shift identifier; this identifier was added during the affected time period and therefore older product may not contain this digit in the
3lot number
Amount recalled
7,659,634 total units

This recall covers 39 products

The agency filed one notice per product. You are reading one of them; the other 38 are below.

26 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

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 Jan 19, 2023 · Data as of Sep 19, 4:53 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.