Assurance Infusion recalls Fentanyl 1000mcg/ml 20mL syringes due to lack of sterility assurance. Affected lots: 12182019@3 exp 12/27/2019.
Lack of sterility assurance.
Assurance Infusion is recalling fentanyl 1000mcg/ml injections in 20mL syringes because they may not be sterile. This could lead to infections if used improperly.
The syringes lack sterility assurance, meaning they could be contaminated with bacteria. If used without proper sterilization, this could cause infections in patients.
Patients using this specific fentanyl injection product are affected. Healthcare providers administering the medication may also be at risk.
Check for the lot number 12182019@3 with expiration date 12/27/2019 on the syringe packaging. The product is a fentanyl 1000mcg/ml injection in a 20mL syringe.
Look for the lot number 12182019@3 and expiration date 12/27/2019 on the syringe packaging.
The product may not be sterile, so it could cause infections if used improperly. Do not use this syringe.
Check for the lot number 12182019@3 with expiration date 12/27/2019 on the syringe packaging.
Do not use the syringe. 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-0729-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0729-2020 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.