Assurance Infusion recalls CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringes due to lack of sterility assurance. Affected lots: 12122019@15, expiring 12/21/2019.
Lack of sterility assurance.
Assurance Infusion is recalling a specific type of syringe for injectable medication because it may not be sterile. This could lead to infections if used improperly. The recall affects certain lots with a specific expiration date.
The syringe may not be sterile, which means it could cause infections when used for injections. This is a serious risk because medical procedures require sterile equipment to prevent contamination and illness.
People who have the specific syringe model with lot number 12122019@15 and expiration date 12/21/2019 are affected. Healthcare providers and patients using this medication are most at risk.
Check for the lot number 12122019@15 on the syringe packaging. The syringe is labeled as CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL. It expires by December 21, 2019.
Look for the lot number 12122019@15 and expiration date 12/21/2019 on the syringe packaging.
The recall states there is a lack of sterility assurance, so it is not safe to use. The product may cause infections if used.
Check for the lot number 12122019@15 and expiration date 12/21/2019 on the syringe packaging.
The recall does not specify a remedy, so contact Assurance Infusion at (713) 533-8800 for further instructions.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0725-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0725-2020 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.
