DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Reported: June 16, 2021 Initiated: April 28, 2021 #D-0604-2021
Product Description
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 25 cases
- Distribution
- Nationwide within the United States
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 25 cases.
Why was this product recalled? ▼
Temperature Abuse: Product exposed to temperature outside specified limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 16, 2021. Severity: Low. Recall number: D-0604-2021.
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