Fresenius Kabi Usa, Llc: Delflex, Dextrose Peritoneal Dialysis Solution With Attached Stay-safe Exchange Set For Intraperitoneal Dialysis Only, 2.5% Dex. Lm/lc, 2l 5pk, Par...
Recall Summary Fresenius Kabi is recalling DELFLEX Dextrose Peritoneal Dialysis Solution 2.5% (2L 5-packs, part number 054-20222) distributed nationwide because some bags may have small holes that could cause leaks and allow contamination. This dialysis solution is used for intraperitoneal dialysis treatment. The recall affects products distributed across all U.S. states and Washington, D.C.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/59213b2b-ddd7-499a-967a-8cea3932beb2