DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and contamination risks. Affected kits include ASC Thyroid Pack 89-6302.14 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 and particles. This could pose a risk of infection or contamination during medical procedures. The recall affects specific kits sold with certain lot numbers and expiration dates.
The gowns may contain unknown levels of bacteria, particles, and microbial growth. This could lead to infections or contamination if used in medical procedures where sterility is critical.
Patients and healthcare providers using DeRoyal Sterile Custom Kits with Cardinal Health gowns are affected. Those with the specific ASC Thyroid Pack 89-6302.14 model and listed lot numbers are most at risk.
Check for the ASC Thyroid Pack 89-6302.14 model. Look for lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, 49310958, or 49675501. The kits may expire by September 1, 2023, or later.
Identify your kit model and lot numbers to confirm if it's affected.
The gowns may contain unknown levels of bacteria, particles, and microbial growth, which could lead to infections during medical procedures.
Check your kit's model and lot numbers. If affected, contact DeRoyal for guidance on next steps.
Yes, some kits expire by September 1, 2023, or later, depending on the lot number.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1416-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1416-2020 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.
