The Recall Desk
ModerateFDA (Devices)·Z-1858-2020·Announced 2020-05-13

R82 A/S Recalls Chest Supports for Loose Plastic Plug

R82 A/S is recalling 2,230 chest supports for the R82 Mustang and Rabbit Up because a plastic plug can come loose without tools.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical or low-risk hazard.

Plain-English summary

R82 A/S is recalling 2,230 units of Chest Support for R82 Mustang (Model Numbers: 861810, 861820, 861830) and Rabbit Up (Model Numbers: 869810, 869820, 869830). The recall was initiated because the plastic plug on the chest support can come loose without the use of a tool.

The affected units were distributed from April 1, 2017, to February 10, 2020. The distribution pattern is listed as NC. The recall is classified as Class II by the U.S. Food and Drug Administration.

Consumers should stop using the affected chest supports and contact R82 A/S for instructions on how to proceed with the recall.

The recalled product

Product
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Manufacturer
R82 A/S
Category
Medical Device — Orthopedic Support
Hazard
Affected units
2,230

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All units distributed from 04/01/2017 to 02/10/2020

Distribution

Distributed in 1 state:

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