Z-1388-2016 Class II Terminated
FDA device recall Z-1388-2016 was initiated by Arjo, Inc. dba ArjoHuntleigh on December 21, 2015 and is designated Class II. Reason for recall: Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose. The recall status is terminated (terminated June 25, 2018). Affected quantity: 1,596 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2016
- Initiation Date
- December 21, 2015
- Termination Date
- June 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,596 units
Product Description
Reason for Recall
Distribution Pattern
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.