Z-0014-2018Class II

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

Name: Z-0014-2018 Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF...
Creator: Handicare AB
Published: 2016-07-28
License: https://open.fda.gov/license/

Direct Healthcare Group Sverige AB / initiated 2016-07-28 / Terminated / root cause: manufacturing process

FDA source

Handicare AB began a recall of Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009 on 2016-07-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0014-2018
Classification: Class II
Status: Terminated
Initiated: 2016-07-28
Posted: 2017-10-11
Terminated: 2018-12-17
Recalling firm: Direct Healthcare Group Sverige AB
Product: Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall by email on 07/28/2017. The firm directed the consignee to repair the units on site and destroy the affected parts.
Quantity in commerce: 9 units
Distribution: OH, PA, MD
Product codes and lots: a) Carina350EM, REF 6060011, Serial numbers: 661102000 - 661102160 b) Carina350EML, REF 60600012, Serial numbers: 661200500 - 661200584 c) Carina350EE, REF 60600009, Serial numbers: 660900500 -660900571

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0014-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0014-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-18	2017-10-11

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)