Assurance Infusion recalls Fentanyl 800mcg/ml 20mL syringes due to lack of sterility assurance. Affected lots expire 12/22/2019. Stop using if you have this product.
Lack of sterility assurance.
Assurance Infusion is recalling Fentanyl 800mcg/ml injections in 20mL syringes because they lack sterility assurance. This could lead to infections if the product is used. The recall affects specific lots with expiration dates ending December 22, 2019.
The syringes lack sterility assurance, meaning they could be contaminated with bacteria or other pathogens. If used for injections, this could cause infections or other health issues in patients. The risk is higher for medical use where sterility is critical.
People who have the specific Fentanyl 800mcg/ml 20mL syringes with lot number 12132019@1 are affected. Healthcare providers using this product for medical injections are most at risk.
Check for the lot number 12132019@1 on the syringe packaging. The product expires December 22, 2019. This recall applies to Fentanyl 800mcg/ml injections in 20mL syringes.
Look for the lot number 12132019@1 on the syringe packaging to confirm if it's affected.
The recall states there is a lack of sterility assurance, so it is not safe to use. The product should be discarded if it has the affected lot number.
If you have the affected lot number 12132019@1, stop using it immediately and contact Assurance Infusion at (713) 533-8800 for further instructions.
Check the lot number on the syringe packaging; affected units have lot number 12132019@1 and expire December 22, 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-0733-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0733-2020 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.
