DeRoyal recalls sterile custom kits with Cardinal Health gowns due to unknown bioburden and microbiological contamination risks. Affected kits include ASC Laparoscopy Pack 89-6138.13 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 during medical procedures if the gowns are not properly sterilized.
The gowns may contain unknown levels of bacteria, microorganisms, and particles that could contaminate surgical sites during procedures. This risk is not fully understood but could lead to infections if the gowns are not properly sterilized.
Healthcare professionals using these kits for laparoscopy procedures are most at risk. Patients undergoing surgery with these kits could be exposed to potential contaminants.
Check for the ASC Laparoscopy Pack 89-6138.13 model with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, or 4418GSJ. The kits were sold with specific expiration dates, including one expiring 10/01/2023.
Identify the lot number and expiration date on the kit packaging to confirm if it is affected.
The recalled kits are the ASC Laparoscopy Pack 89-6138.13 with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ.
The gowns may contain unknown levels of bacteria, microorganisms, and particles that could pose a risk during medical procedures.
The recall record does not specify a remedy.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1415-2020 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1415-2020 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.
