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.
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 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
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.
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