DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and contamination risks. Affected kits include Ophthalmology CSTM PCK 89-6387.08 with specific lot numbers.
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. This could pose a risk to patients during medical procedures if the gowns are used without proper sterilization.
The gowns may contain unknown levels of bacteria, microorganisms, and particles that could lead to infections or contamination during medical procedures. Without knowing the exact contamination levels, the risk to patients and staff cannot be fully assessed.
Healthcare professionals using these kits for ophthalmology procedures are most at risk. Patients receiving treatments with these kits could be exposed to potential contaminants.
Check for the product name 'Ophthalmology CSTM PCK 89-6387.08' on the kit. Look for lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49512592 (expiring 07/01/2022).
Identify the kit's lot number and expiration date to confirm if it's affected.
The recall states the gowns may contain unknown levels of bioburden and contamination, so they are not considered safe for use until the recall is addressed.
The recall record does not specify a remedy, so contact DeRoyal directly for guidance.
Check for the product name 'Ophthalmology CSTM PCK 89-6387.08' and lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49512592 (expiring 07/01/2022).
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1417-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1417-2020 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.
