B. Braun Recalls FreAmine HBC Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection) units due to visible particulate matter found in reserve samples.
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 severity score of at least 4 per the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection), a sterile, single-dose, prescription-only injectable product. The recall involves partial fill containers of 750 mL in a 1000 mL container, identified by Catalog No. S9350-58SS and NDC 0264-9350-55.
The recall was initiated due to the presence of visible particulate matter found in reserve sample units. The affected lots are J2H002 (expiration 06/14) and J2S018 (expiration 12/14). A total of 4,614 units were distributed nationwide, in Puerto Rico, and in Spain.
Healthcare providers and patients should stop using the affected product and contact B. Braun Medical Inc. for further instructions or replacement.
The recalled product
- Product
- 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4,614
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 (4)
- Lot# J2H002
- Exp 06/14
- J2S018
- Exp 12/14
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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