Assurance Infusion recalls 20mL syringes with BUP 2.5MG/CLONI 5MCG/FENT 200MCG/SUF 50MCG/ML (40) due to lack of sterility assurance. Affected lots: 12122019@4 exp 12/21/2019.
Lack of sterility assurance.
Assurance Infusion is recalling a specific 20mL syringe product that contains multiple medications. The recall is due to a lack of sterility assurance, which could lead to infections if used.
The syringe lacks proper sterility assurance, meaning it may not be clean enough to prevent infections. This could lead to serious infections if the syringe is used for injections.
Patients using this syringe for medication injections are affected. Healthcare providers administering these injections are at higher risk.
Check for the lot number 12122019@4 with expiration date 12/21/2019 on the syringe packaging. This specific product contains BUP 2.5MG/CLONI 5MCG/FENT 200MCG/SUF 50MCG/ML (40) in a 20mL syringe.
Look for the lot number 12122019@4 and expiration date 12/21/2019 on the syringe packaging.
The recall states there is a lack of sterility assurance, which could lead to infections if used. However, the official notice does not specify if the syringe is safe to use after a fix.
The recall does not provide a remedy, so the official notice does not specify what to do with the syringe.
Check for the lot number 12122019@4 with expiration date 12/21/2019 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-0689-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0689-2020 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.
