Assurance Infusion recalls Bi-Mix 30 mg/1 mg/mL injection vials due to lack of sterility assurance. Affected lots expire 02/12/2020 and 03/17/2020. No remedy specified in recall notice.
Lack of sterility assurance.
Assurance Infusion is recalling Bi-Mix 30 mg/1 mg/mL injection vials that may not be sterile. This could lead to infections if used improperly. The recall affects specific production lots with known expiration dates.
The vials lack sterility assurance, meaning they could be contaminated with bacteria or other pathogens. If used for injections, this could cause serious infections or other health issues. The risk is present if the vials are not properly sterilized before use.
Patients using Bi-Mix 30 mg/1 mg/mL injection vials from Assurance Infusion are affected. Healthcare providers administering these vials are at risk if they use the recalled lots.
Check for vials labeled 'Bi-Mix 30 mg/1 mg/mL Inj.' with lot numbers 09192019 or 08162019. These vials expire by 03/17/2020 or 02/12/2020 respectively.
Look for lot numbers 09192019 or 08162019 on the vial label.
Assurance Infusion is recalling Bi-Mix 30 mg/1 mg/mL injection vials due to lack of sterility assurance.
Lots 09192019 (expiring 03/17/2020) and 08162019 (expiring 02/12/2020).
The recall notice does not specify a remedy.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0677-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0677-2020 from Assurance Infusion. 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.
