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Terminated

Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.

FDA Recall Z-0698-2008 · Posted 2008-02-05

Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2007-12-10
Date Terminated2008-02-08
Product Quantity64

Reason for Recall

Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.

Firm Action

Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.

Root Cause

Packaging process control

Distribution Pattern

Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.

Official Source

View FDA Recall →

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

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