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Terminated

Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, 534635T, 534637T, 534641T, 534642T, 534643T, 534644T, 534645T, 534646T, 534647T, 534648T, 534649T, 534660T, 534670T, 534672T, 534674T.

FDA Recall Z-1240-06 · Posted 2006-07-13

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2006-06-26
Date Terminated2008-11-19
Product Quantity338,270

Reason for Recall

The tip of the catheter may separate from the body during operation.

Firm Action

The firm sent a letter in June 2006 to its consignees advising them that all impacted lots of Infiniti 6 French catheters (product codes attached) manufactured on Line #1 from July 2005 through February 2006 are being recalled, starting June 26, 2006. The U.S. initial consignee is being contacted directly by Cordis sales reps and other Cordis representatives. The initial consignee is being requested to sign an Acknowledgement Form. The Cordis representative is collecting any units at the consignee, and sending the units back to Cordis for reconciliation and destruction.

Root Cause

Other

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K9708545 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERCordis Corp. · 1997-09-30K9609751-4F INFINITI ANGIOGRAPHIC CATHETERCordis Corp. · 1996-04-02K911310COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MODGe Medical Systems Information Technologies · 1991-06-10

Official Source

View FDA Recall →

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

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