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Terminated

Rifton E-Pacer, SKU K660, powered lift device

FDA Recall Z-0166-2020 · Posted None

Recalling FirmCommunity Products, LLC
Recall StatusTerminated
Product CodeFSA
Date Initiated2019-03-21
Date Terminated2020-06-15
Product Quantity167

Reason for Recall

A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.

Firm Action

Urgent Medical Device Correction emails were sent to customers beginning on March 21, 2019. Customers were contacted via telephone beginning April 5, 2019.

Root Cause

Nonconforming Material/Component

Distribution Pattern

The products were distributed US nationwide. The products were distributed to the following foreign countries: Foreign Countries: Worldwide, including Canada, United Kingdom, Germany, Japan, Singapore, South Korea, United Arab Emirates, Taiwan, Denmark, Italy, Hong Kong, Ireland, Australia, New Zealand, Israel, Colombia, Russia

Official Source

View FDA Recall →

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

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