DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose recall
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
Why was DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose recalled?
Temperature Abuse: Product exposed to temperature outside specified limits.
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) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022
- Product
- DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 39 cases
- Distribution
- Nationwide within the United States
- Recall date
- June 16, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)