Agency classClass IOur severity:Severe FDA (Drugs)·D-1268-2014·Announced 2014-05-07

B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter

B. Braun Medical Inc. is recalling specific lots of Cefazolin Sodium injectable products because visible particulate matter was 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 per the rubric mandates a minimum score of 4 (Severe).

Plain-English summary

B. Braun Medical Inc. is recalling several injectable products, specifically Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container. The recall is due to the presence of visible particulate matter found in reserve sample units.

The affected products are sterile, single-dose, prescription-only medications intended for intravenous use only. The recall covers 136,392 units distributed nationwide, in Puerto Rico, and in Spain. Specific lot numbers and expiration dates are listed in the official recall documentation.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates associated with this recall. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
Brand: CEFAZOLIN SODIUM
Manufacturer: B. Braun Medical Inc
Category: Drug — Injectable Antibiotic
Hazard: particulate-matter
Affected units: 136,392

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 (9)

Lot# H2S725
H2S726
Exp 07/14
H3D724
Exp 11/14
H3E724
Exp 12/14
Lot# H3H507
Exp 01/15

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 →

Same brand · CEFAZOLIN SODIUM

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Critical
B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
FDA (Drugs) · 2014-05-07

Same manufacturer · B. Braun Medical Inc

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