Assurance Infusion recalls 18ml syringes containing 55.5 mcg/ml sufentanil due to lack of sterility assurance. Affected lots: 12122019@19 (exp. 12/21/2019).
Lack of sterility assurance.
Assurance Infusion is recalling 18ml syringes with 55.5 mcg/ml sufentanil 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 for injections, this could cause serious infections or other health issues.
Healthcare providers and patients using this specific syringe product are affected. Those with the lot number 12122019@19 (expiring 12/21/2019) are most at risk.
Check for the lot number 12122019@19 on the syringe packaging. The product expires December 21, 2019, and is sold by Assurance Infusion.
Look for the lot number 12122019@19 on the syringe packaging.
The recall states there is a lack of sterility assurance, so it is not safe to use.
The recall does not specify a remedy, so contact Assurance Infusion at (713) 533-8800 for guidance.
The product expires December 21, 2019, as indicated by the lot number 12122019@19.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0769-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0769-2020 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.
