FDAFDA · Food and drugs·Recall number Z-1090-2021
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.
Published February 17, 2021 · Recall initiated: January 7, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- 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.
- Lot
- All lot numbers from 18KXBXXXXX to 20KXBXXXXX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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