Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The affected products were distributed nationwide.
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, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Assurance Infusion is recalling 2 syringes of a multi-drug injection product containing bupivacaine, clonidine, fentanyl, and sufentanil. The recall is being conducted due to a lack of sterility assurance for the product.
The affected product is identified by Lot 12122019@4 with an expiration date of 12/21/2019. The recall covers products distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected syringes and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 2
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: 12122019@4 Exp. 12/21/2019
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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