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U.S. Department of Health and Human Services

Class 2 Device Recall Carina Mobile Lifts

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  Class 2 Device Recall Carina Mobile Lifts see related information
Date Initiated by Firm July 28, 2016
Create Date October 11, 2017
Recall Status1 Open3, Classified
Recall Number Z-0014-2018
Recall Event ID 78130
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Carina Mobile Lifts, Models:
a) Carina350EM, REF 6060011
b) Carina350EML, REF 60600012
c) Carina350EE, REF 60600009
Code Information a) Carina350EM, REF 6060011, Serial numbers: 661102000 - 661102160, b) Carina350EML, REF 60600012, Serial numbers: 661200500 - 661200584, c) Carina350EE, REF 60600009, Serial numbers: 660900500 -660900571
Recalling Firm/
Manufacturer
Handicare AB
Maskinvagen 17
Lulea Sweden
Manufacturer Reason
for Recall
A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye.
FDA Determined
Cause 2
Process control
Action The firm initiated their recall by email on 07/28/2017. The firm directed the consignee to repair the units on site and destroy the affected parts.
Quantity in Commerce 9 units
Distribution OH, PA, MD
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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