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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 52194
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement. Lot numbers: 58749813, 58802303, 58836847, 58877405, 58909346, 59011910, 59035360, 59085935, 59118391, 59241531, 58705682, 58711964, 58722234, 58771175, 58837337, 58855247, 58904182, 58927518, 58936037, 58936014, 58936027, 59009635, 59030253, 59056470, 59103213, 59124020, 59199172, 59218725, 59235997. Class II Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use. 1524 units Z-1967-2012
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