DeRoyal recalls sterile custom kits with Cardinal Health gowns that may contain unknown bioburden and microbiological contaminants. Affected kits include specific ASC Ocular Plastics Pack models and lot numbers. Consumers should check their product details.
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 might have unknown levels of bacteria and contaminants. This could pose a risk of infection or contamination during medical procedures. The recall affects specific product models and lot numbers sold through certain channels.
The gowns may contain unknown levels of bacteria, microorganisms, and particles. This could lead to infections or contamination if used in sterile medical settings where even small amounts of contaminants are harmful.
Healthcare professionals using these kits for medical procedures are most at risk. Patients receiving care with these kits could also be affected if the gowns cause contamination.
Check for the ASC Ocular Plastics Pack 89-6498.13 model. Look for lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49227281 and 49520963. Products with expiration dates up to August 2023 or September 2023 are affected.
Identify the lot number and expiration date on the packaging to confirm if your kit is affected.
The recall states that the gowns may contain unknown levels of bacteria and contaminants, so they are not considered safe for medical use.
The recall does not specify a remedy, so you should check the product details to confirm if your kit is affected and contact DeRoyal for further instructions.
Check for the ASC Ocular Plastics Pack 89-6498.13 model and lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, or 49227281 and 49520963 with expiration dates up to August 2023 or September 2023.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1419-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1419-2020 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.
