DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and microbiological contamination risks. Affected kits include specific cystoscopy packs and 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 bacteria and contaminants. This could pose a risk of infection during medical procedures if the gowns are used improperly.
The gowns may contain unknown levels of bacteria and other contaminants that could lead to infections if used in medical procedures. Without knowing the exact type or amount of contamination, it's impossible to assess the risk accurately.
Medical professionals using these kits for procedures like cystoscopy are most at risk. Patients receiving these kits could also be affected if the gowns are contaminated.
Check for the cystoscopy pack model 89-6071.15 with specific lot numbers: 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or lot 49442168 expiring 03/01/2021.
Look for the cystoscopy pack model 89-6071.15 with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or lot 49442168 expiring 03/01/2021.
The recalled products are DeRoyal Sterile Custom Kits containing Cardinal Health Gowns, specifically the Cystoscopy Pack 89-6071.15 with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, and lot 49442168 expiring 03/01/2021.
The gowns may contain unknown levels of bacteria and contaminants, which could pose a risk of infection during medical procedures.
The recall record does not specify a remedy, so check the product details to confirm if it is affected and contact DeRoyal for further instructions.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1414-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1414-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
