Recall Z-1858-2020 ยท ITJ Walker, Mechanical
R82 A/S
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
| Date | Mar 6, 2020 |
| Status | Terminated |
| Reason | The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool. |
| 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 | 2230 units |
| Distribution | NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.