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Terminated

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

FDA Recall Z-0860-2009 · Posted 2009-01-23

Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeKOC
Date Initiated2008-11-25
Date Terminated2009-09-24
Product Quantity351,743 units

Reason for Recall

Port may crack and separate resulting in potential blood exposure/blood loss for the patient

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution --- including USA and country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTORFresenius Medical Care · 2002-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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