FDA Enforcement Class II Terminated

Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.

Recall: Z-2381-2015 · Reported August 19, 2015

Enforcement

Recall Number
Z-2381-2015
Event ID
71707
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Etac Supply Center Ab
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
August 19, 2015
Initiation Date
July 12, 2015
Classification Date
August 13, 2015
Termination Date
February 16, 2017
Address
Langgatan 12, N/A, Anderstorp, N/A, N/A, Sweden

Description

Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.

Reason

The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken.

Code Info

The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080

Distribution

Nationwide Distribution including FL, AZ, and CA.

Quantity

13 units