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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

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

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 Letter
Distribution Pattern Nationwide distribution: USA and Puerto Rico