DELFLEX Peritoneal Dialysis Solution recall: Sterility Concern
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Why was DELFLEX Peritoneal Dialysis Solution recalled?
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
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 #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
- Product
- DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 3,734 cases
- Distribution
- Product was distributed throughout the United States to patients and clinics.
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)