Assurance Infusion Recalls Multi-Drug Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific lots of multi-drug syringes because they may lack sterility assurance. Patients should contact their healthcare provider for guidance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which per the rubric corresponds to a severity score of 4 (Severe) when associated with potential adverse health consequences.
Plain-English summary
Assurance Infusion is recalling specific lots of BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringes. The recall is due to a lack of sterility assurance, which means the product may not be sterile as required for medical use.
The affected product is identified by Lot 12102019@3 with an expiration date of 12/19/2019. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients who have received this product should contact their healthcare provider for guidance on next steps. The product was distributed nationwide within the United States.
The recalled product
- Product
- BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 12102019@3 Exp. 12/19/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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