—#194356

Product

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

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K192017
Affected lot / code info: UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Nationwide distribution in the states of Texas and Louisiana.

Timeline

Recall initiated: 2022-06-01
Terminated: 2024-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194356. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.