DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Reported: June 16, 2021 Initiated: April 28, 2021 #D-0605-2021
Product Description
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 672 cases
- Distribution
- Nationwide within the United States
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 672 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-0605-2021.
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