FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
- Recall number
- Z-1311-2022
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
- Status
- Terminated
- Initiated
- 2022-06-01
- Posted
- not on file
- Terminated
- 2024-10-07
- 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.
- Lot, serial or model codes
- UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
- 510(k) numbers
- ["K192017"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28