D-0608-2021 Class III Terminated
FDA drug recall D-0608-2021 was initiated by Fresenius Medical Care Holdings, Inc. on April 28, 2021 and is designated Class III. Reason for recall: Temperature Abuse: Product exposed to temperature outside specified limits. The recall status is terminated (terminated September 17, 2021). Affected quantity: 39 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- June 16, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- September 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 cases
Product Description
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,
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022