FDA (Devices) recall action 87134

Cardinal Health 200, LLC recalled 13 products on 2021-02-17

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2021-02-17
Critical: 0
Units: 387,538,645

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–13 of 13

ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential defects like rips, holes, and foreign material.
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 m
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Kendall Blue Isolation Gowns Due to Defects
Cardinal Health is recalling Kendall Blue Isolation Gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
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
Category
Distribution
47 states
HighFDA (Devices)··2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, and foreign material that may compromise barrier protection.
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
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material.
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 mat
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
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 flui
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats because they may have rips, holes, or open seams that compromise barrier protection.
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 m
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
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 mater
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
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 mat
Category
Distribution
47 states
HighFDA (Devices)··2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
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
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, or foreign material that may compromise barrier protection.
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 ma
Category
Distribution
47 states
HighFDA (Devices)··2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
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 mate
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential manufacturing defects such as rips, holes, and foreign material.
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 ma
Category
Distribution
47 states
ModerateFDA (Devices)··2021-02-17
Cardinal Health Recalls Kendall Blue XXL Gowns Due to Defects
Cardinal Health is recalling Kendall Blue XXL gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
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
Category
Distribution
47 states