Assurance Infusion recalls 20mL syringes with BUP 40mg/FENT 1200mcg/SUF 400mcg/ML due to lack of sterility assurance. Affected lots: 12102019@4, expiring 12/19/2019.
Lack of sterility assurance.
Assurance Infusion is recalling 20mL syringes containing BUP 40mg/FENT 1200mcg/SUF 400mcg/ML due to a lack of sterility assurance. This could lead to infections if the syringe is used.
The syringes lack sterility assurance, meaning they may not be clean enough to prevent infections when used for medical injections. This could lead to serious infections if the syringe is used without proper sterilization.
People who own or use the recalled syringes, especially those receiving medical treatments requiring these injections. Patients using the product for medical purposes are at risk of infection.
Check for the lot number 12102019@4 on the syringe, which expires December 19, 2019. The product is a 20mL syringe containing BUP 40mg/FENT 1200mcg/SUF 400mcg/ML.
Look for the lot number 12102019@4 and expiration date of December 19, 2019 on the syringe.
The recall states there is a lack of sterility assurance, so the product is not safe to use as it could cause infections.
The recall record does not specify a replacement process or remedy.
The recall record does not specify a remedy, so contact Assurance Infusion at (713) 533-8800 for guidance.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0707-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0707-2020 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.
