Medical device recalls Moderate risk

Handicare AB recalls Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Recall date
July 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0014-2018
FDA classification
Class II
Brand / firm
Handicare AB
Sold / distributed
OH, PA, MD

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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