PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: February 17, 2021 Initiated: January 7, 2021 #Z-1094-2021

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
29,810,665 total
Distribution
Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cardinal Health 200, LLC. Units affected: 29,810,665 total.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1094-2021.