Recall Z-0443-2013
Parks Medical Electronics, Inc · initiated August 8, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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…
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: Employee error
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.
Details
- Recall number
- Z-0443-2013
- Initiated
- August 8, 2012
- Posted by FDA
- December 10, 2012
- Terminated
- August 19, 2016
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 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.
- Recalling firm
- Parks Medical Electronics, Inc, Aloha, OR