Assurance Infusion recalls Fentanyl 3000mcg/ml 20mL syringes due to lack of sterility assurance. Affected lots: 12122019@18 and 12162019@24. No remedy specified in official notice.
Lack of sterility assurance.
Assurance Infusion is recalling Fentanyl 3000mcg/ml 20mL syringes because they lack sterility assurance. This could lead to infections if used improperly. The recall affects specific production lots with expiration dates.
The syringes lack sterility assurance, meaning they may not be clean enough to prevent infections when used for injections. This could lead to bacterial contamination and serious health issues if the syringe is used without proper sterilization.
Patients using the recalled syringes for medical injections may be at risk of infection. Healthcare providers administering these syringes should check their lot numbers.
Check for lot numbers 12122019@18 or 12162019@24 on the syringe packaging. The syringes expire by December 21, 2019, or December 25, 2019, respectively.
Look for lot numbers 12122019@18 or 12162019@24 on the syringe packaging.
The official notice does not specify any remedy.
The recalled syringes expire by December 21, 2019, or December 25, 2019, depending on the lot.
Check for lot numbers 12122019@18 or 12162019@24 on the syringe packaging.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0728-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0728-2020 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.
