6.9% FreAmine HBC recall: Particulate Matter
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose…
Why was 6.9% FreAmine HBC recalled?
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# J2H002, Exp 06/14; J2S018, Exp 12/14
- 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…
- Recalling firm
- B. Braun Medical Inc
- Quantity
- 4614 units
- Distribution
- Nationwide, Puerto Rico and Spain
- Recall date
- May 7, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)