Recall Z-1858-2020— R82 A/S

Class II · Terminated

Class II FDA medical device recall by R82 A/S, initiated 2020-03-06, terminated 2023-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830. Reason: The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool..

Recalling firm
R82 A/S
Classification
Class II
Status
Terminated
Initiated
2020-03-06
Terminated
2023-09-05
Firm location
Gedved, N/A, Denmark

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.