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Parks Medical Electronics, Inc recalls Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow ma
Recalled December 5, 2012 · FDA recall Z-0443-2013 · Parks Medical Electronics
Hazard
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. · FDA Class II
Units
349 units (Domestic: 270 units - Foreign: 79 units)
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Parks Medical Electronics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →