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

FDA device recall Z-0443-2013 · posted 2012-12-10 · Terminated

Recall details

Recalling firm

Parks Medical Electronics, Inc

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

DPW

Quantity affected

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, S

Date initiated

2012-08-08

Date posted

2012-12-10

Date terminated

2016-08-19

Location

Aloha, OR

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