Medications & Supplements/Prescription Drugs

Fresenius Medical Care Holdings, Inc.: Dialysis Solutions and Sodium Chloride Recalled for Temperature Abuse

Agency Publication Date: June 9, 2021

Summary

Fresenius Medical Care is recalling approximately 1,127 units of various dialysis solutions and Sodium Chloride (saline) injections because the products were exposed to temperatures outside of their required storage limits. This temperature abuse occurred during distribution and may affect the safety or effectiveness of these medical treatments. The affected products include DELFLEX Peritoneal Dialysis Solutions and Sodium Chloride 0.9% USP injections in various sizes. Consumers should contact their healthcare provider or pharmacist for guidance and to check if they have received any of the impacted lots.

Risk

Exposure to temperatures outside of specified limits can compromise the chemical stability or integrity of the solution, potentially leading to ineffective treatment or unforeseen adverse health effects for patients undergoing dialysis.

What You Should Do

Check your medical supplies for Sodium Chloride 0.9%, USP (1000 mL) with NDC 46163-0300-10 and lot number 20NG02095 (Exp. October 2021).
Check for DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose, 5000 mL) with NDC 49230-0188-50 and lot number 20JU01001 (Exp. February 2022).
Identify affected DELFLEX 2.5% Dextrose solutions by lot: 20PU03043 (Exp. June 2022), 20SU03036 (Exp. July 2022), 20Su07012 (Exp. July 2022), or 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019 (Exp. August 2022).
Identify affected DELFLEX 4.25% Dextrose solutions (5000 mL) with NDC 49230-0212-50 and lots 21AK01022 (Exp. July 2022) or 20SK01022 (Exp. June 2022).
Check for DELFLEX solutions with attached 'stay safe' Exchange sets: Lot 20SU02032 (1.5% Dextrose), Lot 20PU02010 or 20SU04033 (2.5% Dextrose), and Lot 20PU04030 (4.25% Dextrose).
Check for DELFLEX 1.5% Dextrose (3000 mL or 5000 mL) with lot 20SU03060 (Exp. July 2022) or lots 21AU02015, 21AU02038 (Exp. August 2022).
Contact your healthcare provider or pharmacist immediately for guidance. Do not use these products if the lot numbers match your supply. Return any unused product to the pharmacy for a refund and contact Fresenius Medical Care Holdings, Inc. for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Sodium Chloride 0.9%, USP (1000 mL)

Model:

NDC 46163-0300-10

Lot Numbers:

20NG02095 (Exp. October 2021)

Product: DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL)

Model:

NDC 49230-0188-50

Lot Numbers:

20JU01001 (Exp. February 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low Magnesium, Low Calcium (3000 mL or 5000 mL)

Model:

NDC 49230-0209-23

NDC 49230-209-30

NDC 49230-209-50

Lot Numbers:

20PU03043 (Exp. June 2022)

20SU03036 (Exp. July 2022)

20Su07012 (Exp. July 2022)

21AU07021 (Exp. August 2022)

21AU02037 (Exp. August 2022)

21AU01007 (Exp. August 2022)

21AU01006 (Exp. August 2022)

21AU01019 (Exp. August 2022)

Product: DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium (5000 mL)

Model:

NDC 49230-0212-50

Lot Numbers:

21AK01022 (Exp. July 2022)

20SK01022 (Exp. June 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set (2000 mL)

Model:

NDC 49230-206-92

Lot Numbers:

20SU02032 (Exp. July 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set (2500 mL or 2000 mL)

Model:

NDC 49230-209-94

NDC 49230-209-92

Lot Numbers:

20PU02010 (Exp. June 2022)

20SU04033 (Exp. July 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set (2000 mL)

Model:

NDC 49230-212-92

Lot Numbers:

20PU04030 (Exp. June 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium (3000 mL or 5000 mL)

Model:

NDC 49230-206-30

NDC 49230-206-50

Lot Numbers:

20SU03060 (Exp. July 2022)

21AU02015 (Exp. August 2022)

21AU02038 (Exp. August 2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87907

Status: Resolved

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: hospitals; dialysis clinics; pharmacies

Manufactured In: United States

Units Affected: 8 products (48 cases; 25 cases; 672 cases; 49 cases; 5 cases; 39 cases; 4 cases; 285 cases)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for Sodium Chloride 0.9%, USP (1000 mL) with NDC 46163-0300-10 and lot number 20NG02095 (Exp. October 2021).

Check for DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose, 5000 mL) with NDC 49230-0188-50 and lot number 20JU01001 (Exp. February 2022).

Identify affected DELFLEX 2.5% Dextrose solutions by lot: 20PU03043 (Exp. June 2022), 20SU03036 (Exp. July 2022), 20Su07012 (Exp. July 2022), or 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019 (Exp. August 2022).

Identify affected DELFLEX 4.25% Dextrose solutions (5000 mL) with NDC 49230-0212-50 and lots 21AK01022 (Exp. July 2022) or 20SK01022 (Exp. June 2022).

Check for DELFLEX solutions with attached 'stay safe' Exchange sets: Lot 20SU02032 (1.5% Dextrose), Lot 20PU02010 or 20SU04033 (2.5% Dextrose), and Lot 20PU04030 (4.25% Dextrose).

Check for DELFLEX 1.5% Dextrose (3000 mL or 5000 mL) with lot 20SU03060 (Exp. July 2022) or lots 21AU02015, 21AU02038 (Exp. August 2022).

Contact your healthcare provider or pharmacist immediately for guidance. Do not use these products if the lot numbers match your supply. Return any unused product to the pharmacy for a refund and contact Fresenius Medical Care Holdings, Inc. for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Sodium Chloride 0.9%, USP (1000 mL)

Model:

NDC 46163-0300-10

Lot Numbers:

20NG02095 (Exp. October 2021)

Product: DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL)

Model:

NDC 49230-0188-50

Lot Numbers:

20JU01001 (Exp. February 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low Magnesium, Low Calcium (3000 mL or 5000 mL)

Model:

NDC 49230-0209-23

NDC 49230-209-30

NDC 49230-209-50

Lot Numbers:

20PU03043 (Exp. June 2022)

20SU03036 (Exp. July 2022)

20Su07012 (Exp. July 2022)

21AU07021 (Exp. August 2022)

21AU02037 (Exp. August 2022)

21AU01007 (Exp. August 2022)

21AU01006 (Exp. August 2022)

21AU01019 (Exp. August 2022)

Product: DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium (5000 mL)

Model:

NDC 49230-0212-50

Lot Numbers:

21AK01022 (Exp. July 2022)

20SK01022 (Exp. June 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set (2000 mL)

Model:

NDC 49230-206-92

Lot Numbers:

20SU02032 (Exp. July 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set (2500 mL or 2000 mL)

Model:

NDC 49230-209-94

NDC 49230-209-92

Lot Numbers:

20PU02010 (Exp. June 2022)

20SU04033 (Exp. July 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set (2000 mL)

Model:

NDC 49230-212-92

Lot Numbers:

20PU04030 (Exp. June 2022)

Product: DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium (3000 mL or 5000 mL)

Model:

NDC 49230-206-30

NDC 49230-206-50

Lot Numbers:

20SU03060 (Exp. July 2022)

21AU02015 (Exp. August 2022)

21AU02038 (Exp. August 2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87907

Status: Resolved

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sold By: hospitals; dialysis clinics; pharmacies

Manufactured In: United States

Units Affected: 8 products (48 cases; 25 cases; 672 cases; 49 cases; 5 cases; 39 cases; 4 cases; 285 cases)

Distributed To: Nationwide