DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Reported: January 10, 2024 Initiated: December 28, 2023 #D-0218-2024
Product Description
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Reason for Recall
Lack of Sterility Assurance
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 69,590 bags
- Distribution
- Nationwide within the United States
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 69,590 bags.
Why was this product recalled? ▼
Lack of Sterility Assurance
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 10, 2024. Severity: Moderate. Recall number: D-0218-2024.
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