Recall Z-0860-2009 ยท KOC Accessories, Blood Circuit, Hemodialysis
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: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
| Date | Jan 23, 2009 (initiated Nov 25, 2008) |
| Status | Terminated |
| Reason | Port may crack and separate resulting in potential blood exposure/blood loss for the patient |
| 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 | 351,743 units |
| Distribution | Worldwide Distribution --- including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR Fresenius Medical Care, Oct 30, 2002 |