Reported Mar 11, 2020 · Terminated
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Deroyal Industries, Inc. Lafollette
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Deroyal Industries, Inc. Lafollette · 1501 E Central Ave · La Follette, TN · 37766-2892
Is this the product you have?
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
- Sold as the followingOutpatient Major 89-3865.12
- Lot codes and dates
Catalog number 9541NAlot numbers 2708DJ13008DJ13008DSJ1 and 4418GSJOutpatient Major 89-3865.12
- Lot numbers
47061206 exp. 06/01/202249505579 exp. 03/01/20234955103 exp. 03/01/2023
- Amount recalled
- 2,100 units total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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