Fresenius Medical Care Holdings, Inc.: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary Fresenius Medical Care is recalling five models of 5008X blood tubing sets used in dialysis treatment due to potential connection errors when attaching the SafeLine to the substitution fluid port on the 5008X CAREsystem. The affected products were distributed nationwide across multiple states. This is a Class II recall, indicating a potential health risk but not an immediate life-threatening situation.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
- Reason
- Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3f228bb8-d640-4357-ab27-bdcb32d9f47f