Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2381-2015Class II

Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and...

Etac Supply Center AB / initiated 2015-07-12 / Terminated / root cause: manufacturing process

Etac Supply Center Ab began a recall of 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... on . FDA classified it as Class II and gives the reason as "The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2381-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Etac Supply Center AB
Product
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.
Product code
ILS Adaptor, Hygiene
Reason for recall
The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken.
Root cause tag
manufacturing process
FDA root cause
Process design
Action
Etac sent an Urgent Field Safety Notice dated July 2015 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that there was no reason for an immediate stop of using Relax, however, as an intermediate precautionary action awaiting replacement, consumers were requested to be observant and inspect the Relax to see if there are visible signs of a crack. Customers with questions were advised to contact their Etac distributor or the Etac coordinator at 1-800-336-7684 or fax 1-704-882-0751.
Quantity in commerce
13 units
Distribution
Nationwide Distribution including FL, AZ, and CA.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2381-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2381-2015Class IITerminatedVoluntary: Firm initiated