DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and contamination risks. Affected kits include Shoulder Pack 89-4751.08 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, microbes, and particles. This could pose a health risk during medical procedures if the gowns are used improperly.
The gowns may contain unknown levels of bacteria, microbes, and particles. If used in medical procedures without proper sterilization, this could lead to infections or other health issues for patients or users.
People who own or use DeRoyal Sterile Custom Kits with Cardinal Health gowns, especially those in healthcare settings. Medical professionals using these kits for procedures are at higher risk due to potential contamination.
Check for the Shoulder Pack 89-4751.08 model with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49505405 (expiring 11/01/2021). These kits were sold with specific catalog numbers and lot numbers.
Identify your kit's model number and lot numbers to confirm if it's affected.
The recall states the gowns may contain unknown levels of bacteria, microbes, and particles, so they are not considered safe for medical use without further testing.
The recall record does not specify a remedy, so contact DeRoyal directly for guidance on next steps.
Check for the Shoulder Pack 89-4751.08 model with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49505405 (expiring 11/01/2021).
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1412-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1412-2020 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.
