Fresenius Medical Care Holdings, Inc.: Drug Recall

Recall #D-0610-2021 · 04/28/2021

Class III: Low Risk

Recall Details

Recall Number: D-0610-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Fresenius Medical Care Holdings, Inc.
Status: Terminated
Date Initiated: 04/28/2021
Location: Waltham, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 285 cases

Reason for Recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Product Description

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451

Distribution Pattern

Nationwide within the United States

Other Recalls by Fresenius Medical Care Holdings, Inc.

Class II: Risk 10/25/2025

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Class II: Risk 08/29/2025

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Class II: Risk 05/27/2025

Lack of Assurance of Sterility
Class II: Risk 04/29/2025

Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Class II: Risk 12/05/2024

Potential for internal blood leaks due to cracked polyurethane

View all recalls by Fresenius Medical Care Holdings, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.