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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Recall Number Z-0914-2013
Classification Class II
Code Info Lot #1210099
Product Distributed Qty 2340
Reason For Recall The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.

Event Detail

Event Id 64464
Product Type Devices
Status Ongoing
Recalling Firm Churchill Medical Systems, Inc.
City Dover
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.