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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Event Detail

Event ID 63862
Product Type Devices
Status Ongoing
Recalling Firm B. Braun Medical, Inc.
City Allentown
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-23
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040. Class II Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps. 13,078 Z-0623-2013
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