Agency classClass IIOur severity:High FDA (Drugs)·D-0942-2018·Announced 2018-07-25

Avella Recalls Ropivacaine Infusion Bags Due to Sterility Concerns

Avella of Deer Valley, Inc. is recalling 20 bags of 0.2% Ropivacaine infusion cassettes due to potential leakage that compromises sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of assurance of sterility in a medical infusion product, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Avella of Deer Valley, Inc. is voluntarily recalling 20 bags of 0.2% Ropivacaine, 0.9% Sodium Chloride, USP single-dose infusion cassettes. The product is identified by Lot 5/14/18 0722 47-00287Y with an expiration date of 06/28/2018. The recall was initiated because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The recalled product was distributed nationwide in the USA. The specific product description indicates it was prepared for Parkland Memorial Hospital by Advanced Pharma. The NDC number for the product is 15082-002-87.

Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above. If you have questions regarding this recall, please contact the recalling firm, Avella of Deer Valley, Inc.

The recalled product

Product: 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Infusion Solution
Hazard: sterility
leakage
Affected units: 20

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 5/14/18 0722 47-00287Y EXP 06/28/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 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 38 products in this recall →

Same manufacturer · Avella of Deer Valley, Inc. Store 38

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Same hazard · sterility