Drug product
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
D-0609-2021
Product summary
- Event
- Event 87907
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 cases
- Official record key
drug-enforcement:D-0609-2021
Official wording
Reason: Temperature Abuse: Product exposed to temperature outside specified limits.
Code information: Lot #: 20PU04030, Exp. date June 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Temperature Abuse: Product exposed to temperature outside specified limits.