FDAClass IIApril 20, 2016

The Concerto Basic Shower Trolley is intended for recall

The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as…

Why was The Concerto Basic Shower Trolley is intended for recalled?

Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Concerto & Basic Shower Trolleys manufactured by ArjoHuntleigh Polska Sp. z o.o, March 7, 2014 through April 20, 2015 with serial numbers from P0227559 - P0322393

Product
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as…
Recalling firm
Arjo, Inc. dba ArjoHuntleigh
Quantity
1,596 units
Distribution
US Consignees; 222 units distributed in the following states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV. ***Foreign Consignees; 1374 units distributed in the following countries: Australia, Austria, Belgium, Bosnia & Hercegovina, Brazil, CANADA, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Lithuania, Luxemburg, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan and UK.
Recall date
April 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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