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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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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
Distribution Pattern Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports. Lot #1210099 Class II 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. 2340 Z-0914-2013