Assurance Infusion recalls FENT 900MCG/SUF 210MCG/ML 20mL syringes due to lack of sterility assurance. This may cause infections if used.
Lack of sterility assurance.
Assurance Infusion is recalling FENT 900MCG/SUF 210MCG/ML injections in 20 mL syringes because they lack sterility assurance. Using these syringes could lead to infections if they are not properly sterilized.
The syringes lack sterility assurance, meaning they may not be clean enough to prevent infections. If used without proper sterilization, this could lead to infections in the user.
People who own or use Assurance Infusion FENT 900MCG/SUF 210MCG/ML injections in 20 mL syringes. Those with medical conditions requiring injections are at higher risk.
Check for the product name 'FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe' from Assurance Infusion. Lot numbers starting with 12122019@3 and expiration date 12/21/2019.
Identify the product by checking the lot number (12122019@3) and expiration date (12/21/2019).
The recall states there is a lack of sterility assurance, so it is not safe to use without proper sterilization.
Look for the product name 'FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe' with lot number 12122019@3 and expiration date 12/21/2019.
The recall does not specify a remedy, so contact Assurance Infusion at (713) 533-8800 for further instructions.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0727-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0727-2020 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.
