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Terminated

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

FDA Recall Z-1311-2022 · Posted None

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2022-06-01
Date Terminated2024-10-07
Product Quantity3 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.

Firm Action

On June 1, 2022, the firm reached out to its affected customers via telephone to explain the product issue. Customers were instructed to identify and segregate the affected product immediately and remove the product from inventory. If customers had any product to return, the recalling firm would have a customer service representative follow up with the customer. Customers were reminded to always inspect packaging for leaks.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of Texas and Louisiana.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020-04-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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