D-0609-2021 Class III Terminated
FDA drug recall D-0609-2021 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: 4 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
- 4 cases
Product Description
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
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 20PU04030, Exp. date June 2022