B. Braun Recalls ProcalAmine Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling ProcalAmine injectable products 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 minimum severity score of 4 according to the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL containers. The recall affects 18,090 units of the prescription-only, sterile, single-dose product manufactured by B. Braun Medical Inc. in Irvine, California.
The recall was initiated because visible particulate matter was found in reserve sample units. The affected product is identified by Lot# J2K023 with an expiration date of 02/14. The product was distributed nationwide, as well as in Puerto Rico and 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
- ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 18,090
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# J2K023
- Exp 02/14
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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