Date Initiated by Firm | June 25, 2014 |
Date Posted | July 09, 2014 |
Recall Status1 |
Terminated 3 on April 15, 2015 |
Recall Number | Z-2023-2014 |
Recall Event ID |
68399 |
Product Classification |
Chair, adjustable, mechanical - Product Code INN
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Product | Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family. |
Code Information |
Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707). |
Recalling Firm/ Manufacturer |
Invacare Corporation 1200 Taylor St Elyria OH 44035-6248
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For Additional Information Contact | Invacare recall support line 440-329-6595 |
Manufacturer Reason for Recall | The Aquatec Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame. |
FDA Determined Cause 2 | Device Design |
Action | The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing. |
Quantity in Commerce | 465 units |
Distribution | Distributed in PA and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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