Drug 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,
D-0608-2021
Product summary
- Event
- Event 87907
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39 cases
- Official record key
drug-enforcement:D-0608-2021
Official wording
Reason: Temperature Abuse: Product exposed to temperature outside specified limits.
Code information: Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Temperature Abuse: Product exposed to temperature outside specified limits.