Reported Jul 15, 2026 · Ongoing
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
03-5110-6. | 5008X HD Pre-Flush Standard Blood Tubing Set |
03-5160-1. | 5008X HD Pre-Flush With Twister Blood Tubing Set |
03-5300-3. | 5008X HD/HDF Standard Blood Tubing Set |
03-5300-3C. | 5008X HD/HDF With CLiC Blood Tubing Set |
03-5350-8. | 5008X HD/HDF With Twister Blood Tubing Set |
- Amount recalled
- 113,544 units (4,731 cases)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Fresenius Medical Care Holdings, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.