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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 63136
Product Type Devices
Status Ongoing
Recalling Firm C.R. Bard, Inc., Urological Division
City Covington
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: USA and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog # 165808, Lot # NGWA1111 Class II 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. 4,032 units Z-0010-2013