Agency classClass IIOur severity:Severe FDA (Drugs)·D-0946-2018·Announced 2018-07-25

Avella Recalls Fentanyl and Ropivacaine Cassettes Due to Sterility Concerns

Avella of Deer Valley is recalling 100 fentanyl and ropivacaine cassettes due to potential bag leakage and 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 severity score of 4 (Severe) according to the rubric, as it involves a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 100 single-dose cassettes containing fentanyl and ropivacaine. The recall is being conducted due to a lack of assurance of sterility, specifically caused by potential leakage of the bags.

The affected product is a 150 mL single-dose cassette containing fentanyl citrate, ropivacaine HCl, and sodium chloride. The specific lot number is 5/14/18 1012 172-27886Y, with a beyond-use date of June 28, 2018. The product was manufactured by Advanced Pharma and distributed nationwide in the USA.

Healthcare providers and patients should stop using the affected cassettes immediately. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC…
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 100

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 (2)

Lot #: 5/14/18 1012 172-27886Y
BUD 6/28/2018.

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