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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiovascular blood flowmeter

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  Class 2 Device Recall Cardiovascular blood flowmeter see related information
Date Initiated by Firm August 08, 2012
Date Posted December 10, 2012
Recall Status1 Terminated 3 on August 19, 2016
Recall Number Z-0443-2013
Recall Event ID 63235
510(K)Number K944495  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Parks Medical Electronics, Inc
19460 SW Shaw St
Aloha OR 97007-1242
For Additional Information Contact Tech Support
888-356-9522
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action The firm, Parks Medical Electronics, Inc., sent an "IMPORTANT SAFETY ISSUE SERIOUS HEALTH CONSEQUENCE" letter, dated September 10 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers are advised to order LUER UPGRADE KIT WITH MPI if the Parks device includes a Multi Port Inflator (MPI), and/or order the LUER UPGRADE KIT WITHOUT MPI the Parks device does not have a Multi Port Inflator. While waiting for the kit or its installation, consignees/customers should use extreme caution when hooking up the air supply tubes to the cuff's Luer fittings. For ordering your kit, please call 800-547-6427 option 0. For responses, questions or concerns, customer should contact Parks Medical Electronics at 888-356-9522 (Phone), 503-591-9753 (Fax) or send email to support@parksmed.com.
Quantity in Commerce 349 units (Domestic: 270 units - Foreign: 79 units)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DPW and Original Applicant = PARKS MEDICAL ELECTRONICS, INC.
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