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Terminated

Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

FDA Recall Z-2023-2014 · Posted 2014-07-09

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeINN
Date Initiated2014-06-25
Date Terminated2015-04-15
Product Quantity465 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Distributed in PA and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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