Class 3 Device Recall Rectal Tubes 22 French/20 French

• Date Initiated by Firm: October 28, 2010
• Date Posted: November 26, 2010
• Recall Status: Terminated on March 31, 2011
• Recall Number: Z-0465-2011
• Recall Event ID: 57117
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014
• Code Information: Catalog Number: 8006370, Lot number GFUC3605
• FEI Number: 1018233
• Recalling Firm/ Manufacturer: C.R. Bard, Inc., Urological Division; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: Mary Mayo; 770-784-6120
• Manufacturer Reason for Recall: The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.
• FDA Determined Cause: Employee error
• Action: Bard sent an Urgent Product Recall Notification letter dated October 28, 2010 to the consignee. They were instructed to return any outstanding inventory of the affected product. They were advised to notify their consignees of the recall and to retrieve relevant product from those locations. Affected products received by Bard Medical will be destroyed. BMD can be contacted at 1 770 784-6969 for questions or assistance.
• Quantity in Commerce: 108 eaches
• Distribution: Nationwide Distribution: In the state of Ohio.
• 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.