NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Summary
The FDA issued a Class II for NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 by Fresenius Medical Care Holdings, Inc.. Reason: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological co.
Details
Source
Device Recall
External ID
Z-1311-2022
Action Date
2022-07-13
Status
Terminated
Category
device
Product Description
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Lot/Code Info: UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Quantity Affected: 3 cases
Reason for Recall
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
Distribution
US Nationwide distribution in the states of Texas and Louisiana.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-01
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 120 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-1311-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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