Assurance Infusion recalls 20mL syringes with BUP 15mg/CLON 400mcg/FENT 6000mcg/ML INJ due to lack of sterility assurance. Affected lots: 12132019@5 (exp. 12/22/2019).
Lack of sterility assurance.
Assurance Infusion is recalling a specific 20mL syringe containing BUP 15mg/CLON 400mcg/FENT 6000mcg/ML INJ due to a lack of sterility assurance. This could lead to infections if used improperly. The recall covers a specific lot number with an expiration date of December 2019.
The syringe lacks sterility assurance, meaning it could be contaminated with bacteria or other pathogens. If used for injections, this could lead to infections or other health complications. The risk is not specified in terms of severity or likelihood.
Patients using this specific syringe for medication administration are affected. Healthcare providers using the product for injections may also be at risk.
Check for the lot number 12132019@5 on the syringe packaging. The expiration date is December 2019. This product was sold with the manufacturer's phone number (713) 533-8800.
Look for the lot number 12132019@5 and expiration date of December 2019 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 or returned.
The recall does not specify a remedy, so contact Assurance Infusion at (713) 533-8800 for guidance.
Check for the lot number 12132019@5 and expiration date of December 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-0684-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0684-2020 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.
