The Recall Desk
HighFDA (Devices)·Z-0014-2018·Announced 2017-10-18

Handicare Recalls Carina Mobile Lifts Due to Small Locking Pin

Handicare AB is recalling nine Carina mobile lifts because they were delivered with locking pins that are too small. This defect may cause increased wear on internal components.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a mechanical defect in a medical device that could lead to component failure (wear on piston rod eye), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Handicare AB is recalling nine units of Carina mobile lifts, including models Carina350EM, Carina350EML, and Carina350EE. The affected units were distributed in Ohio, Pennsylvania, and Maryland.

The recall is due to a manufacturing error where the mobile lifts were delivered with locking pins that are smaller than the correct size. According to the source, using a locking pin that is too small is likely to cause increased wear on the plastic bushings. Continued use of the device may result in wear on the metal of the piston rod eye.

Consumers who have these specific units should stop using them and contact Handicare AB for further instructions. The recall covers specific serial number ranges for each model as identified in the agency's notice.

The recalled product

Product
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Manufacturer
Handicare AB
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • a) Carina350EM
  • REF 6060011
  • Serial numbers: 661102000 - 661102160 b) Carina350EML
  • REF 60600012
  • Serial numbers: 661200500 - 661200584 c) Carina350EE
  • REF 60600009
  • Serial numbers: 660900500 -660900571

Distribution

Distributed in 3 states:

Same manufacturer · Handicare AB

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