Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
This recall has been terminated (originally issued December 3, 2005).
- Recall Initiated
- November 3, 2005
- Posted
- December 3, 2005
- Terminated
- January 24, 2006
- Recall Number
- Z-0268-06
- Quantity
- 480 units
- Firm Location
- Covington, GA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for the lumen to collapse and prevent passage over a guidewire.
Distribution
Nationwide, Belgium, Canada
Lot / Code Info
Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451.
Root Cause
Other
Action Taken
Consignees were notified via overnight courier on 11/7&8/2005
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