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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1858-2020 | Class II | Terminated | Voluntary: Firm initiated |
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