Class 3 Device Recall BardiaComplete Foley Kit

• Date Initiated by Firm: February 10, 2004
• Date Posted: February 27, 2004
• Recall Status: Terminated on July 09, 2004
• Recall Number: Z-0562-04
• Recall Event ID: 28310
• Product Classification: Catheter, Urological - Product Code KOD
• Product: BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.
• Code Information: Catalog Number: 800518, Lot Number: 76IN0317
• FEI Number: 1018233
• Recalling Firm/ Manufacturer: C.R. Bard, Inc., Urological Division; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: Vivian Stephens; 800-526-4455 Ext. 6902
• Manufacturer Reason for Recall: The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
• FDA Determined Cause: Other
• Action: Consignees were notified by certified mail on 02/10/2004.
• Quantity in Commerce: 1100 units (110 cases)
• Distribution: AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.
• 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.