DeRoyal recalls sterile custom kits with ICU Medical MicroClave Clear Connectors due to potential contamination. Affected kits include specific lots and expiration dates; contact DeRoyal for details.
Procedure packs contained a recalled product.
DeRoyal is recalling sterile custom medical kits that contain ICU Medical MicroClave Clear Connectors. The recall is because these kits may have been contaminated during manufacturing, which could lead to infection risks for patients.
The kits may contain contaminated connectors due to a manufacturing issue. This contamination could lead to infections if the connectors are used in medical procedures without proper sterilization.
Healthcare facilities using DeRoyal Sterile Custom Kits with ICU Medical MicroClave Clear Connectors are likely affected. Patients receiving care through these kits face the highest risk of infection.
Check for kits labeled 'NS CVR PREP PACK /89-6817.09' or 'NON-STERILE IR ADMISSION KIT / 89-8762.05' with specific lot numbers and expiration dates listed in the recall notice.
Look for the product codes and lot numbers listed in the recall notice to determine if your kit is affected.
The recall states that the kits may contain contaminated connectors, so they should not be used until the manufacturer confirms they are safe.
Check the product codes and lot numbers listed in the recall notice to see if your kit matches the affected items.
The recall does not specify a remedy, so contact DeRoyal directly for guidance on next steps.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1668-2022 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1668-2022 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.
