DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and contamination risks. Affected kits include specific lot numbers and catalog codes. Consumers should contact DeRoyal for details.
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
DeRoyal is recalling sterile custom kits that include Cardinal Health gowns because these gowns may contain unknown levels of harmful bacteria and particles. Using them could pose health risks, especially for people who rely on sterile medical equipment.
The gowns may contain unknown levels of bacteria, microorganisms, and particles that could lead to infections or health issues when used in sterile medical settings. The exact risk level is not clearly stated in the recall.
Healthcare workers and patients using DeRoyal Sterile Custom Kits with Cardinal Health gowns are most at risk. The recall affects specific lot numbers and catalog codes sold through ASC.
Check for the catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, or 4418GSJ on the kit packaging. The kits were sold under the ASC General Pack 89-6015.16 label.
Reach out to DeRoyal Industries, Inc. Lafollette for specific instructions on how to handle the recalled kits.
The gowns may contain unknown levels of bacteria, microorganisms, and particles that could lead to infections or health issues.
The affected kits include the ASC General Pack 89-6015.16 with catalog number 9541NA and specific lot numbers: 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ.
Look for the catalog number 9541NA or lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, or 4418GSJ on the kit packaging.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1413-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1413-2020 from DeRoyal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
