Fresenius Medical Care Holdings, Inc.: Drug Recall

Recall #D-0015-2023 · 10/11/2022

Class II: Risk

Recall Details

Recall Number: D-0015-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Fresenius Medical Care Holdings, Inc.
Status: Ongoing
Date Initiated: 10/11/2022
Location: Waltham, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,006 cases of twelve bags each

Reason for Recall

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Product Description

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

Distribution Pattern

Nationwide in the USA

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.