DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and contamination risks. Affected kits include Outpatient Major 89-3865.12 with specific lot numbers. Consumers should check their kit details and contact DeRoyal for guidance.
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 bacteria, microorganisms, and particles. This could pose a risk of infection during medical procedures if the gowns are used improperly.
The gowns may contain unknown levels of bacteria, microorganisms, and particles. If used during medical procedures without proper sterilization, this could lead to infections or other health issues.
Patients and healthcare providers using DeRoyal Sterile Custom Kits with Cardinal Health gowns for medical procedures are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check your DeRoyal Sterile Custom Kit for the model number 'Outpatient Major 89-3865.12' and lot numbers like 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, 47061206, 49505579, or 4955103. The kits were sold with specific expiration dates.
Identify your DeRoyal Sterile Custom Kit's model number and lot numbers to confirm if it is affected.
The gowns in the kits may contain unknown levels of bacteria, microorganisms, and particles, which could pose infection risks during medical procedures.
The recall record does not specify a remedy, so contact DeRoyal directly for guidance.
Check for the model number 'Outpatient Major 89-3865.12' and lot numbers listed in the recall, such as 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, 47061206, 49505579, or 4955103.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1410-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1410-2020 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.
