Medline recalls Hudson RCI Addipak 5mL vials for potential sterility failure. Affected units may have been shipped to customers without proper testing.
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Medline Industries is recalling Hudson RCI Addipak vials that were inadvertently shipped to customers after a sterility failure investigation. This could mean the vials are no longer safe for inhalation use.
The vials were found to have a sterility failure during an investigation and were inadvertently shipped to customers. This means the vials may not be safe for inhalation use, as they could contain contaminants that cause infection.
Patients using the Hudson RCI Addipak vials for inhalation therapy may be affected. Those who received the vials with lot code 3B085 or UDI/DI 140267047147818 are most at risk.
Check for the lot code 3B085 or UDI/DI number 140267047147818 on the vial packaging. The product is labeled as Hudson RCI Addipak, 5mL Sterile 0.9% NaCl Solution for Inhalation USP.
Look for lot code 3B085 or UDI/DI 140267047147818 on the vial packaging.
The vials were found to have a sterility failure during an investigation and were inadvertently shipped to customers.
Check for lot code 3B085 or UDI/DI number 140267047147818 on the vial packaging.
The official recall notice does not specify a remedy or action for affected vials.
We’ve drafted a message you can send Medline Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-2514-2023 — Medline Industries Medline Industries Hello, I own a Medline Industries that is covered by recall Z-2514-2023 from Medline Industries. 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.
