Cardinal Health 200, LLC: Medical Device Recall in 2021 - (Recall #: Z-1095-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 7, 2021

Date Posted: February 17, 2021

Recall Number: Z-1095-2021

Event ID: 87134

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.

Status: Ongoing

Product Quantity: 29,810,665 total

Code Information:

All lot numbers from 1901XXK to 2010XXK

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated