FDA recall Z-0014-2018

Handicare AB · Class II · device

Product

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

OH, PA, MD

Key facts

Status: Terminated
Initiation date: 2016-07-28
Report date: 2017-10-18
Termination date: 2018-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lulea, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0014-2018