← FDA ENFORCEMENT
D-0218-2024Class II

Fresenius Medical Care Holdings, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Fresenius Medical Care Holdings, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-01-10
Distribution
Nationwide within the United States
Firm state
MA
Product quantity
69,590 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Sterility Assurance

Product description

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

Code / lot info

Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →