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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Event Detail

Event ID 62774
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 2012-06-29
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: USA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags. Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764) Class II Incomplete seal on sterile packages of product. 56,694 units Z-2327-2012