The Recall Desk
SevereFDA (Drugs)·D-1275-2014·Announced 2014-05-07

B. Braun Recalls Hyperlyte CR Injectable Due to Particulate Matter

B. Braun Medical Inc. is recalling Hyperlyte CR injectable products because visible particulate matter was found in reserve sample units.

What this means for you

Illness, injury, or structural failure has been reported. 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 per the rubric.

Plain-English summary

B. Braun Medical Inc. is recalling Hyperlyte CR (Multi-Electrolyte Concentrate) injectable products. The recall is due to the presence of visible particulate matter found in reserve sample units.

The affected product is Hyperlyte CR, 20 mL/dose, 250 mL Container, Catalog No. S9432, NDC 0264-1943-20. The specific lot involved is Lot# J3B007 with an expiration date of 08/14. The recall covers 5,592 units distributed nationwide, in Puerto Rico, and in Spain.

Consumers and healthcare providers should stop using the affected product and contact B. Braun Medical Inc. for further instructions or a replacement.

The recalled product

Product
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
Manufacturer
B. Braun Medical Inc
Category
Drug — Injectable
Hazard
Affected units
5,592

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# J3B007
  • Exp 08/14

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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