Dianeal Low Calcium recall: Sterility Concern
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare…
Why was Dianeal Low Calcium recalled?
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
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 #: Y281477, Expiry: 02/2020
- Product
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 29,370 bags
- Distribution
- Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
- Recall date
- January 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)