Agency classClass IIOur severity:Severe FDA (Drugs)·D-0951-2018·Announced 2018-07-25

Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

Avella of Deer Valley, Inc. is recalling 25 bags of Magnesium Sulfate in Sodium Chloride due to potential 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 Severe rating under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 25 bags of MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). The product is a single-dose bag with a volume of 102 mL, manufactured by Avella of Houston and intended for Salt Lake Regional Med Ctr. The specific lot number is 5/15/18 0510 169-90610P, with a beyond-use date of 8/13/2018.

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. This defect poses a risk of contamination to the sterile solution.

The affected product was distributed nationwide in the USA. Consumers and healthcare facilities should stop using the recalled product and contact the manufacturer or their supplier for further instructions.

The recalled product

Product: MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — IV Solution
Hazard: sterility
leakage
Affected units: 25

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 #: 5/15/18 0510 169-90610P
BUD 8/13/2018.

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