Fresenius Medical Care North America CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
Brand
Fresenius Medical Care North America
Lot Codes / Batch Numbers
Lot number 8LR902 only
Products Sold
Lot number 8LR902 only
Fresenius Medical Care North America is recalling CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, wit due to Port may crack and separate resulting in potential blood exposure/blood loss for the patient. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
Recommended Action
Per FDA guidance
Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026