Recall Z-2073-2015 ยท ILS Adaptor, Hygiene
Etac Supply Center Ab
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.
| Date | Jul 15, 2015 (initiated Jun 15, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 25 units |
| Distribution | Nationwide Distribution including GA, CT and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.