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U.S. Department of Health and Human Services

Class 2 Device Recall 8 Fr. Bardex Pediatric AllSilicone Foley Catheter

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  Class 2 Device Recall 8 Fr. Bardex Pediatric AllSilicone Foley Catheter see related information
Date Initiated by Firm September 07, 2012
Date Posted October 04, 2012
Recall Status1 Terminated 3 on March 21, 2013
Recall Number Z-0010-2013
Recall Event ID 63136
510(K)Number K821745  
Product Classification Catheter, urological - Product Code KOD
Product 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Code Information Catalog # 165808, Lot # NGWA1111
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 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
FDA Determined
Cause 2		 Employee error
Action An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.
Quantity in Commerce 4,032 units
Distribution Nationwide distribution: USA and Puerto Rico
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 = KOD and Original Applicant = C.R. BARD, INC.
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