Assurance Infusion recalls BUP 40mg/fent 3000mcg/ml 20mL syringes due to lack of sterility assurance. Affected lots: 12102019@5, expiring 12/19/2019.
Lack of sterility assurance.
Assurance Infusion is recalling a specific 20mL syringe containing BUP 40mg/fent 3000mcg/ml due to a lack of sterility assurance. This could lead to infections if used improperly.
The syringe lacks sterility assurance, meaning it could be contaminated with bacteria or other pathogens. If used for injections, this could cause serious infections or other health issues.
Patients using this syringe for medication injections may be affected. Healthcare providers administering the medication are at higher risk.
Check for the lot number 12102019@5 on the syringe packaging. The syringe expires December 19, 2019.
Look for the lot number 12102019@5 and expiration date of December 19, 2019 on the syringe packaging.
The recall states there is a lack of sterility assurance, so it is not safe to use.
Check for the lot number 12102019@5 and expiration date of December 19, 2019 on the syringe packaging.
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-0708-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0708-2020 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.
