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U.S. Department of Health and Human Services

Class 2 Device Recall Supporter toilet armrest

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  Class 2 Device Recall Supporter toilet armrest see related information
Date Initiated by Firm June 15, 2015
Date Posted July 15, 2015
Recall Status1 Terminated 3 on July 14, 2017
Recall Number Z-2073-2015
Recall Event ID 71515
Product Classification Adaptor, hygiene - Product Code ILS
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.
Code Information Serial numbers higher than 224017
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 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.
FDA Determined
Cause 2		 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.
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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