Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1858-2020Class II

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

R82 a/S / initiated 2020-03-06 / Terminated / root cause: design

R82 A/S began a recall of Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 on . FDA classified it as Class II and gives the reason as "The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1858-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
R82 a/S
Product
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Product code
ITJ Walker, Mechanical
Reason for recall
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
2230 units
Distribution
NC
Product codes and lots
All units distributed from 04/01/2017 to 02/10/2020

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1858-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1858-2020Class IITerminatedVoluntary: Firm initiated