The Recall Desk
SevereFDA (Drugs)·D-0768-2020·Announced 2020-01-22

Assurance Infusion Recalls Sufentanil Syringes Due to Sterility Concerns

Assurance Infusion is recalling specific lots of Sufentanil 300mcg/mL injection syringes due to a lack of sterility assurance.

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 corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Assurance Infusion is recalling Sufentanil 300mcg/mL injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance for the product.

The affected product is identified by Lot 12162019@9 with an expiration date of 12/25/2019. The recall number is D-0768-2020. The product was distributed nationwide within the United States.

Healthcare providers and consumers should stop using the affected product and contact Assurance Infusion at (713)-533-8800 for further instructions.

The recalled product

Product
SUFENTANIL 300MCG/ML INJ 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: 12162019@9 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

Same manufacturer · Assurance Infusion

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Same hazard · sterility failure

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