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Terminated

Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

FDA Recall Z-0268-06 · Posted 2005-12-03

Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeEZN
Date Initiated2005-11-03
Date Terminated2006-01-24
Product Quantity480 units

Reason for Recall

There is a potential for the lumen to collapse and prevent passage over a guidewire.

Firm Action

Consignees were notified via overnight courier on 11/7&8/2005

Root Cause

Other

Distribution Pattern

Nationwide, Belgium, Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993840BARD UROFORCE BALLOON DILATION CATHETERC.R. Bard, Inc. · 2000-01-31

Official Source

View FDA Recall →

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

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