Recall Z-0443-2013— Parks Medical Electronics, Inc

Name: FDA recall Z-0443-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-08

Class II · Terminated

Class II FDA medical device recall by Parks Medical Electronics, Inc, initiated 2012-08-08, terminated 2016-08-19. It names one FDA 510(k) clearance: K944495. 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.. Reason: 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..

Recalling firm: Parks Medical Electronics, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-08-08
Terminated: 2016-08-19
Firm location: Aloha, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K944495 — MODEL 3200 VASCULAR MINI-LABParks Medical Electronics, Inc.·cleared 1995-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.