Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific lots of a multi-drug injection syringe due to a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 corresponds to a Severe severity score under the rubric for significant injury or health risks.
Plain-English summary
Assurance Infusion is recalling a specific lot of a multi-drug injection product containing baclofen, buprenorphine, clonazepam, fentanyl, and morphine. The product is packaged in a 20 mL syringe.
The recall was initiated due to a lack of sterility assurance. The affected lot number is 12162019@2, with an expiration date of 12/25/2019. The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injection
- 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: 12162019@2 Exp. 12/25/2019
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.
See all 118 products in this recall →Related recalls
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