Z-0443-2013Class II

Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular...

Name: Z-0443-2013 Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular...
Creator: Parks Medical Electronics, Inc
Published: 2012-08-08
License: https://open.fda.gov/license/

Parks Medical Electronics Inc / initiated 2012-08-08 / Terminated / root cause: manufacturing process

FDA source

Parks Medical Electronics, Inc began a recall of Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with... on 2012-08-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0443-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-08
Posted: 2012-12-10
Terminated: 2016-08-19
Recalling firm: Parks Medical Electronics Inc
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.
Product code: DPW Flowmeter, Blood, Cardiovascular
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected].
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0443-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0443-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27

Product code DPW

K944495Class IIModel 3200 Vascular Mini-LabParks Medical Electronics, Inc. / cleared 1995-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)