Summary
The FDA issued a Class II for Dialyzer Optiflux 160NRe by Fresenius Medical Care Holdings, Inc.. Reason: Potential for internal blood leaks due to cracked polyurethane.
Details
Source
Device Recall
External ID
Z-0801-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
Dialyzer Optiflux 160NRe
Lot/Code Info: UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Quantity Affected: 5,351 cases (64,212 dialyzers)
Reason for Recall
Potential for internal blood leaks due to cracked polyurethane
Distribution
Nationwide Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-05
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 137 device recalls issued in the same week, part of 403 device-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 "Z-0801-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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