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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
Recall Number Z-0443-2013
Classification Class II
Code Info Domestic Distribution: 013053, 013104, 013107, 013124, 013154, 013182, 013193, 014203, 014237, 014248, 014249, 014252, 014253, 014254, 014269, 014276, 014310, 014335, 014339, 014361, 014366, 014376, 014380, 014381, 014382, 014384, 014397, 014401, 014406, 014416, 014424, 014429, 014431, 014443, 014444, 014448, 014454, 014458, 014530, 014532, 014533, 014540, 014542, 014545, 014547, 014551, 014552, 014552, 014553, 014598, 014601, 014604, 014608, 014616, 014654, 014657, 014659, 014660, 014661, 014663, 103077, 105X-600001024, 105X-600001025, 105X-600001026, 105X-600001027, 105X-800001019, 105X-800001022, 105X-800001023, 105X-800001024, 105X-800001026, 105X-800001027, 105X-800001027, 105X-800001028, 105X-800001029, 105X-800001030, 105X-800001031, 105X-E00001001, 105X-E00001002, 105X-E00001003, 105X-E00001004, 105X-E00001005, 105X-E00001007, 105X-E00001008, 105X-E00001009, 105X-E00001010, 105X-E00001011, 105X-E00001012, 105X-E00001013, 105X-E00001014, 105X-E00001016, 105X-E00001017, 105X-E00001018, 105X-E00001019, 105X-E00001020, 105X-F00001000, 105X-F00001001, 105X-F00001002, 105X-F00001003, 105X-F00001004, 105X-F00001005, 105X-F00001005, 105X-F00001006, 105X-F00001007, 105X-F00001008, 105X-F00001009, 105X-F00001010, 105X-F00001011, 105X-F00001012, 105X-F00001013, 105X-F00001014, 105X-F00001015, 105X-F00001016, 105X-F00001017, 105X-F00001018, 105X-F00001020, 105X-F00001021, 105X-F00001022, 105X-F00001023. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify. Foreign distribution: 01301, 013043, 013044, 013045, 013046, 013072, 013076, 013175, 013181, 013183, 013188, 014215, 014386, 014392, 014393, 014456, 014535, 014550, 014551, 014561, 014562, 014563, 105X-800001025, 105X-922001017, 105X-922001018, 105X-922001019, 105X-922001021, 105X-9221020, 105X-923001001, 105X-923001002, 105X-923001003, 105X-923001004, 105X-923001005, 105X-923001006, 105X-923001007, 105X-923001007, 105X-923001009, 105X-923001010, 105X-923001011, 105X-E00001000, 105X-E00001003, 105X-E00001006, 105X-E00001015, 105X-F00001019. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify.
Product Distributed Qty 349 units (Domestic: 270 units - Foreign: 79 units)
Reason For Recall Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.

Event Detail

Event Id 63235
Product Type Devices
Status Ongoing
Recalling Firm Parks Medical Electronics, Inc
City Aloha
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-08
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela.
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