Cardinal Health 200, LLC: There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Agency Publication Date: February 5, 2021

Affected Products

Product: Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

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Product: Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

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Product: Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

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Product: Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

Product: Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 1901XXK to 2010XXK

Lot Numbers:

numbers

Product: Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 1901XXK to 2010XXK

Lot Numbers:

numbers

Product: Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

All lot numbers from 1901XXK to 2010XXK

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87134

Status: Active

Manufacturer: Cardinal Health 200, LLC

Manufactured In: United States

Units Affected: 13 products (29,810,665 total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

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All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Lot Numbers:

numbers

All lot numbers from 1901XXK to 2010XXK

Lot Numbers:

numbers

All lot numbers from 1901XXK to 2010XXK

Lot Numbers:

numbers

All lot numbers from 1901XXK to 2010XXK

Lot Numbers:

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