Recall Z-2073-2015— Etac Supply Center Ab

Class II · Terminated

Class II FDA medical device recall by Etac Supply Center Ab, initiated 2015-06-15, terminated 2017-07-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm
Etac Supply Center Ab
Classification
Class II
Status
Terminated
Initiated
2015-06-15
Terminated
2017-07-14
Firm location
Anderstorp, N/A, Sweden

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.