Fresenius Medical Care Holdings, Inc.: Drug Recall

Recall #D-0777-2023 · 05/23/2023

Class II: Risk

Recall Details

Recall Number: D-0777-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Fresenius Medical Care Holdings, Inc.
Status: Terminated
Date Initiated: 05/23/2023
Location: Waltham, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 53,424 bags

Reason for Recall

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

Product Description

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

Distribution Pattern

Product was distributed to 32 clinics in SC, NC and VA.

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.