Dianeal Low Calcium recall: Particulate Matter
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare…
Why was Dianeal Low Calcium recalled?
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
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 #: C940700, C940841, Exp 05/16
- Product
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 50,530 bags
- Distribution
- Nationwide
- Recall date
- October 8, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)