DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose recall
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Why was DELFLEX Peritoneal Dialysis Solution with 1.5% 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) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
- Product
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 285 cases
- Distribution
- Nationwide within the United States
- Recall date
- June 16, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)