FDA recall record

Handicare AB Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF recall — FDA Z-0014-2018

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…

Class IIclassification
Z-0014-2018official record ID
Oct 18, 2017report date

Recall record at a glance

Official recordZ-0014-2018
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmHandicare AB
Report dateOct 18, 2017
Recall initiation dateJul 28, 2016
Quantity9 units
LocationLulea, Sweden

Official product description

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

Why the product 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.

Distribution information

OH, PA, MD

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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