0.9% Sodium Chloride Irrigation USP recall: Particulate Matter
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01…
Why was 0.9% Sodium Chloride Irrigation USP recalled?
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
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?
Batch # J7N912, Exp 10/31/20
- Product
- 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01…
- Recalling firm
- B. Braun Medical Inc
- Quantity
- 17,360 plastic irrigation containers
- Distribution
- Nationwide in the USA
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)