Assurance Infusion recalls 20mL syringes with BUP 8MG/CLON 100MCG/HYDROM 20MG/ML due to lack of sterility assurance. Affected lots: 12122019@5, expiring 12/21/2019.
Lack of sterility assurance.
Assurance Infusion is recalling 20mL syringes containing BUP 8MG/CLON 100MCG/HYDROM 20MG/ML because they may not be sterile. This could lead to infections if used improperly.
The syringes lack sterility assurance, meaning they might contain contaminants that could cause infections when injected. This is a serious risk for medical use but the exact mechanism isn't specified in the recall.
Patients using this specific syringe for medical injections are affected. Healthcare providers administering these injections are at higher risk.
Check for the lot number 12122019@5 on the syringe packaging. The syringes expire December 21, 2019, and were sold with the manufacturer's phone number (713) 533-8800.
Look for the lot number 12122019@5 on the syringe packaging.
The recall states there is a lack of sterility assurance, so it is not safe to use. The product should be discarded.
The recall does not specify a remedy, so contact Assurance Infusion at (713) 533-8800 for guidance.
Check for the lot number 12122019@5 on the syringe packaging. The syringes expire December 21, 2019.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0718-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0718-2020 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.
