Recall Z-0318-2009 ยท INN Chair, Adjustable, Mechanical
Community Products, LLC
Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. The product is used as a hip strap chair for children.
| Date | Dec 5, 2008 (initiated Sep 12, 2008) |
| Status | Terminated |
| Reason | Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard. |
| Root cause | Process control |
| Action | On 9/12/08, Rifton Equipment began notifying the customers by phone using a phone script. This phone call notified the customers of the recall and also served as an effectiveness check that they were notified. The customers were instructed to remove the product from use until the replacement kit is received and the old strap is returned. The replacement kit contains instructions with ID codes and a place for the customer to verify that they have made the replacement as instructed. It also contains the required number of new hip straps. A verification check was sent with the replacement stra |
| Quantity | Potentially 147 units may be affected. |
| Distribution | Worldwide Distribution including USA and countries of Spain and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.