Assurance Infusion recalls QUADMIX 1mL vials with lack of sterility assurance. Affected lots: 07012019@30 expiring 12/28/2019. Stop using if you have this product.
Lack of sterility assurance.
Assurance Infusion is recalling QUADMIX 1mL vials due to a lack of sterility assurance. This could lead to infections if the product is used. Affected vials have lot number 07012019@30 and expire December 28, 2019.
The vials lack sterility assurance, meaning they could be contaminated with bacteria. If used, this could cause serious infections in patients. The risk is higher for those with compromised immune systems.
Healthcare professionals and patients using QUADMIX 1mL vials with lot number 07012019@30. Those who have the vials before expiration date are most at risk.
Check for vials labeled 'QUADMIX 1mL' with lot number 07012019@30. The expiration date is December 28, 2019. This product was sold by Assurance Infusion.
Immediately discard any QUADMIX 1mL vials with lot number 07012019@30.
Lot number 07012019@30.
December 28, 2019.
Check for vials labeled 'QUADMIX 1mL' with lot number 07012019@30.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0763-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0763-2020 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.
