Recall Z-1858-2020

R82 A/S · initiated March 6, 2020

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830

Codes / lots: All units distributed from 04/01/2017 to 02/10/2020

Reason for recall

The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.

FDA-determined cause: Device Design

Action taken

R82, Inc. notified their sole consignee on 02/09/2020 by email. The notice identified the choking hazard and requested that the consignee notify their customers of the hazard. The consignee will be sending letters beginning the week of 03/16/2020 to their customers.

Details

Recall number
Z-1858-2020
Initiated
March 6, 2020
Terminated
September 5, 2023
Product code
ITJ – Walker, Mechanical
Quantity
2230 units
Distribution
NC
Recalling firm
R82 A/S, Gedved

Official FDA recall record