Agency classClass IOur severity:Severe FDA (Drugs)·D-1265-2014·Announced 2014-05-07

B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve sample units.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

B. Braun Medical Inc. is recalling 53,592 units of 0.9% Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container. The recall was initiated because visible particulate matter was found in reserve sample units.

The affected product is identified by Catalog No. S8004-5384, NDC 0264-1800-31, Lot# J2P912, and an expiration date of 02/14. The product is a prescription-only intravenous injection manufactured by B. Braun Medical Inc. in Irvine, CA.

The recall covers distribution in the United States, Puerto Rico, and Spain. Healthcare providers and patients should discontinue use of the affected lots and contact the manufacturer or their local FDA office for further instructions.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: B. Braun Medical Inc
Category: Drug — Injectable
Hazard: particulate-matter
Affected units: 53,592

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# J2P912
Exp 02/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by B. Braun Medical Inc 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 12 products in this recall →

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