Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1827-2017Class II

Ferno PROFlexx Model 28Z Chair Cot

Ferno-Washington Inc / initiated 2017-03-08 / Terminated / root cause: manufacturing process

Ferno-Washington Inc began a recall of Ferno PROFlexx Model 28Z Chair Cot on . FDA classified it as Class II and gives the reason as "The recall was initiated as a result of the detection of an incorrect nut used in manufacturing". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1827-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ferno-Washington Inc
Product
Ferno PROFlexx Model 28Z Chair Cot
Product code
FPO Stretcher, Wheeled
Reason for recall
The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
Root cause tag
manufacturing process
FDA root cause
Mixed-up of materials/components
Action
Consignees were contacted via telephone and email on 3/8/17. No product will be returned to the recalling firm. The firm and its service company will correct each product in the field at the customers location.
Quantity in commerce
34 units
Distribution
Worldwide distribution. The recalled products were distributed to the following states: CA, FL, HI, IL, NY, OH. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. The recalled product was distributed to the following countries: Taiwan, United Arab Emirates, Thailand, Singapore
Product codes and lots
17E003185, 17E003169, 17E003179, 17E003180, 17E003181, 17E003183, 17E003187, 17E003152, 17E003168, 17E003171, 17E003172, 17E003173, 17E003184, 17E003170, 17E003138, 17E003139, 17E003140, 17E003141, 17E003153, 17E003154, 17E003155, 17E003156, 17E003157, 17E003158, 17E003159, 17E003160, 17E003161, 17E003162, 17E003163, 17E003164, 17E003165, 17E003166, 17E003167, 17E003174

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1827-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1827-2017Class IITerminatedVoluntary: Firm initiated