Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0105-2019Class II

Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations

Liko AB / initiated 2018-07-17 / Terminated / root cause: manufacturing process

Liko AB began a recall of Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations on . FDA classified it as Class II and gives the reason as "The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in potential injury to the patient". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0105-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Liko AB
Product
Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in potential injury to the patient.
Root cause tag
manufacturing process
FDA root cause
Storage
Action
The customer was contacted via telephone on 7/17/18 to notify them of the recall. An Urgent Field Safety Notice notification letter was sent to the customer on 7/19/18.
Quantity in commerce
2
Distribution
The products were distributed to the following US states: OH.
Product codes and lots
Part Number 3136250, the manufacturing date is on the right side of the label listed as 2017-05-05.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0105-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0105-2019Class IITerminatedVoluntary: Firm initiated