Assurance Infusion recalls 20mL syringes with BUP 23mg/Hydrom 25mg/Suf 100mcg/ml injection due to lack of sterility assurance. Affected lots: 12162019@15 exp 12/25/2019.
Lack of sterility assurance.
Assurance Infusion is recalling 20mL syringes containing a specific medication mix because they lack sterility assurance. This could lead to infections if used improperly.
The syringes do not have proper sterility assurance, meaning they could be contaminated with bacteria or other pathogens. This poses a risk of infection if the syringe is used for injections.
Patients using the recalled syringes for medication injections. Those with medical conditions requiring precise dosing may be at higher risk.
Check for the lot number 12162019@15 with expiration date 12/25/2019 on the syringe packaging. The product contains BUP 23mg/Hydrom 25mg/Suf 100mcg/ml in 20mL.
Look for the lot number 12162019@15 and expiration date 12/25/2019 on the syringe packaging.
No, the syringes lack sterility assurance and could cause infections if used.
Check for lot number 12162019@15 with expiration date 12/25/2019 on the packaging.
Contact Assurance Infusion at (713) 533-8800 to confirm if your syringe is affected.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0696-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0696-2020 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.
