DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med
Summary
The FDA issued a Class II for DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, package by Fresenius Medical Care Holdings, Inc.. Reason: Lack of Sterility Assurance.
Details
Source
Drug Recall
External ID
D-0218-2024
Action Date
2024-01-10
Status
Ongoing
Category
drug
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.
Lot/Code Info: Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Quantity Affected: 69,590 bags
Reason for Recall
Lack of Sterility Assurance
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-28
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 72 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0218-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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