FDA Recall Terminated

R82 by ETAC Push Brace for High-Low

Recall: Z-0569-2022 · Initiated December 8, 2021

Recall

Recall Number
Z-0569-2022
Event Number
89236
FEI Number
3001657382
Product Code
INN
Status
Terminated
Root Cause
Process control
Initiated
December 8, 2021
Terminated
September 5, 2023
Address
R82 A/S Parallelvej 3 Gedved Denmark

Description

R82 by ETAC Push Brace for High-Low

Reason

The chrome surface of the push brace can crack during use, potentially cutting the user.

Action

A notification dated 12/10/2021 was sent to customers by R82 A/S notifying them of a Field Safety Notice concerning Push Brace 8910545 attached to patient mobility chairs. The notice communicates the chrome surface's potential for cracking during use, posing a risk of cutting the caregiver utilizing the push brace. The firm instructs customers to visually inspect recalled push braces before use and should be disposed of if any are detected. The firm also communicated that customers with affected push braces will receive replacements. If product has been further distributed, the notice needs to be forwarded on.

Distribution

Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom.

Quantity

396 units