Recall Z-1311-2022 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
| Date | Jun 1, 2022 |
| Status | Terminated |
| Reason | 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 | Under Investigation by 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. |
| Quantity | 3 cases |
| Distribution | US Nationwide distribution in the states of Texas and Louisiana. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC, Apr 24, 2020 |