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Class 2 Device Recall Carina Mobile Lifts |
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Date Initiated by Firm |
July 28, 2016 |
Create Date |
October 11, 2017 |
Recall Status1 |
Terminated 3 on December 17, 2018 |
Recall Number |
Z-0014-2018 |
Recall Event ID |
78130 |
Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
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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
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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.
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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
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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