Z-0860-2009

CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access...

Name: Z-0860-2009 CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access...
Creator: Fresenius Medical Care North America
Published: 2008-11-25
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2008-11-25 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care North America began a recall of CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code... on 2008-11-25. The reason FDA records is "Port may crack and separate resulting in potential blood exposure/blood loss for the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0860-2009
Status: Terminated
Initiated: 2008-11-25
Posted: 2009-01-23
Terminated: 2009-09-24
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
Product code: KOC Accessories, Blood Circuit, Hemodialysis
Reason for recall: Port may crack and separate resulting in potential blood exposure/blood loss for the patient
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 351,743 units
Distribution: Worldwide Distribution --- including USA and country of Canada.
Product codes and lots: Lot Numbers: 8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271.

Product code KOC

K022536Class II\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving ConnectorFresenius Medical Care / cleared 2002-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)