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U.S. Department of Health and Human Services

Class 2 Device Recall Linet

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 Class 2 Recall
Linet
see related information
Date Posted January 13, 2012
Recall Status1 Terminated on July 20, 2012
Recall Number Z-0738-2012
Recall Event ID 60857
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
Code Information Model numbers: 1GZ, 1GV, IS, 1GM, 1AG, 1MC and 1L.
Recalling Firm/
Manufacturer
Linet Americas Inc
10430 Harris Oak Blvd
Ste A
Charlotte, North Carolina 28269-7511
For Additional Information Contact Craig Kallmayer
704-248-5650
Manufacturer Reason
for Recall
The premature failure of the Remote Handset buttons may result in unintended movement of the bed.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Linet sent a notification letter dated December 9, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken. The letter states that firm Linet has decided to do a voluntary field correction to replace the recalled product. The replacement will be completed by the territory Representative (Linet Employee) who will replace the affected product for each customer personally. The replacement takes approximately 30 seconds and does not require the patient to be moved. For questions or concerns call 704-248-5650.
Quantity in Commerce 29,252 units
Distribution Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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