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U.S. Department of Health and Human Services

Class 2 Device Recall Etac Relax

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  Class 2 Device Recall Etac Relax see related information
Date Initiated by Firm July 12, 2015
Date Posted August 13, 2015
Recall Status1 Terminated 3 on February 16, 2017
Recall Number Z-2381-2015
Recall Event ID 71707
Product Classification Adaptor, hygiene - Product Code ILS
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.
Code Information 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
Recalling Firm/
Manufacturer		 Etac Supply Center Ab
Langgatan 12
Anderstorp Sweden
For Additional Information Contact Angela Stegall
800-336-7684
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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