Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Devices includes a Multi Port Inflator or without Multi Port Recalled by Parks Medical Electronics, Inc Due to Parks Medical Electronics, Inc. was made aware of...

Date: August 8, 2012
Company: Parks Medical Electronics, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Parks Medical Electronics, Inc directly.

Affected Products

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.

Quantity: 349 units (Domestic: 270 units - Foreign: 79 units)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Parks Medical Electronics, Inc

Parks Medical Electronics, Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report