Recall Z-0014-2018— Handicare AB
Class II · Terminated
Class II FDA medical device recall by Handicare AB, initiated 2016-07-28, terminated 2018-12-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009. Reason: 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..
- Recalling firm
- Handicare AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-28
- Terminated
- 2018-12-17
- Firm location
- Lulea, Sweden
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.