Assurance Infusion recalls SUFENTANIL 300MCG/ML 20mL syringes due to lack of sterility assurance. Affected lots: 12162019@9, expiring 12/25/2019. No remedy specified in recall notice.
Lack of sterility assurance.
Assurance Infusion is recalling SUFENTANIL 300MCG/ML 20mL syringes because they lack sterility assurance. This could lead to infections if used improperly. The recall affects specific lots with an expiration date of December 25, 2019.
The syringes lack sterility assurance, meaning they may not be clean enough to prevent infections. This poses a risk of contamination during medical procedures, potentially leading to serious infections if the syringe is used.
Healthcare professionals and patients using the recalled syringes for pain management. Those with the specific lot number 12162019@9 are most at risk.
Check for the lot number 12162019@9 on the syringe packaging. The syringes expire by December 25, 2019. This recall applies to Assurance Infusion's SUFENTANIL 300MCG/ML 20mL syringes.
Look for the lot number 12162019@9 on the syringe packaging or label.
The recall notice does not specify any remedy.
The recalled syringes expire on December 25, 2019.
Check for the lot number 12162019@9 on the syringe packaging or label.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0768-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0768-2020 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.
