Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2073-2015Class II

Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips...

Etac Supply Center AB / initiated 2015-06-15 / Terminated / root cause: manufacturing process

Etac Supply Center Ab began a recall of Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount... on . FDA classified it as Class II and gives the reason as "The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2073-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Etac Supply Center AB
Product
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
Product code
ILS Adaptor, Hygiene
Reason for recall
The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
Etac sent an Urgent Notice of Field Correction beginning June 15, 2015, to all affected consignees. The letter directed the consignees to do an in field correction with replacement Fast Nuts. Defined replacement instructions were included with the replacement nuts. Customers with questions were instructed to contact their Etac distributor or the Etac coordinator, Snug Seal Inc. at 1-800-336-7683. For questions regarding this recall call 1-800-367-6844.
Quantity in commerce
25 units
Distribution
Nationwide Distribution including GA, CT and PA.
Product codes and lots
Serial numbers higher than 224017

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2073-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2073-2015Class IITerminatedVoluntary: Firm initiated