Z-0014-2018 Class II Terminated
FDA device recall Z-0014-2018 was initiated by Handicare AB on July 28, 2016 and is designated Class II. 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 likel… The recall status is terminated (terminated December 17, 2018). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2017
- Initiation Date
- July 28, 2016
- Termination Date
- December 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
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.
Distribution Pattern
OH, PA, MD
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