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U.S. Department of Health and Human Services

Class 2 Device Recall Bard UroForce

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  Class 2 Device Recall Bard UroForce see related information
Date Initiated by Firm November 03, 2005
Date Posted December 03, 2005
Recall Status1 Terminated 3 on January 24, 2006
Recall Number Z-0268-06
Recall Event ID 34037
510(K)Number K993840  
Product Classification Dilator, Catheter, Ureteral - Product Code EZN
Product Bard UroForce¿ Balloon Dilation Catheter with Glissando¿ Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
Code Information 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.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact John C. Knorpp
770-874-6451
Manufacturer Reason
for Recall		 There is a potential for the lumen to collapse and prevent passage over a guidewire.
FDA Determined
Cause 2		 Other
Action Consignees were notified via overnight courier on 11/7&8/2005
Quantity in Commerce 480 units
Distribution Nationwide, Belgium, Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EZN and Original Applicant = C.R. BARD, INC.
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