DeRoyal recalls sterile custom kits with Cardinal Health gowns that may contain unknown levels of bioburden and microbiological contamination. Affected kits include Chronic Ear Pack 89-4393.17 with specific lot numbers. Consumers should check their product 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 might have unknown levels of harmful bacteria and particles. This could pose a risk of infection or contamination during medical procedures.
The gowns may contain unknown levels of bacteria, microorganisms, and particles. This could lead to infections or contamination if used in medical procedures without proper sterilization.
People who own or use DeRoyal Sterile Custom Kits with Cardinal Health gowns, especially those using the Chronic Ear Pack 89-4393.17 model. Medical professionals and patients undergoing ear procedures are most at risk.
Check for the Chronic Ear Pack 89-4393.17 model. Look for lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49241024 (expiring 07/01/2020).
Identify your kit's model and lot numbers to confirm if it's affected.
The Chronic Ear Pack 89-4393.17 model with specific lot numbers: 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, and 49241024 (expiring 07/01/2020).
The gowns may contain unknown levels of bacteria, microorganisms, and particles, which could lead to infections if used in medical procedures.
The recall record does not specify a remedy, so check your product details to see if it's affected and contact DeRoyal for further guidance.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1411-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1411-2020 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.
