Class 3 Device Recall Rifton Toddler Chair

• Date Initiated by Firm: September 12, 2008
• Date Posted: December 05, 2008
• Recall Status: Terminated on March 15, 2010
• Recall Number: Z-0318-2009
• Recall Event ID: 49572
• Product Classification: Toddler Chair - Product Code INN
• Product: 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.
• Code Information: Serial Numbers: E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC, E78020080703AD, E77020080701AD, E77020080701AA, E77020080701AB, E76020080704AA, E78020080704AA, E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC, E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA, E76020080709AA, E78020080709AB, E77020080709AA, E77020080709AB, E77020080709AC, E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE, E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA, E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF, E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB, E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB, E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE, E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC, E78020080719AA, E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA, E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC, E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE, E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA, E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC, E78020080725AA, E77020080725AA, E77020080725AB, E78020080728AB, E77020080728AA, E78020080728AA, E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB, E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB, E77020080802AB, E77020080802AC, E78020080801AC, E77020080801AF, E77020080801AA, E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC, E77020080801AD, E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC, E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA, E77020080731AA, E77020080802AA, E77020080809AA, E77020080809AB, E78020080806AF, E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA, E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB, E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB, E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE, E78020080812AG and E78020080812AH. The code is located underneath the seat of the chair.
• Recalling Firm/ Manufacturer: Community Products, LLC; 2032 Route 213; Rifton NY 12471
• For Additional Information Contact: Ryan Burke; 845-658-8351
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 straps, which the customer will sign and return to the firm verifying that they have replaced the straps for the affected serial numbers. Rifton Equipment is providing the customer with return shipping labels which were sent by UPS 2nd day air. The replacement straps use black thread instead of tan thread for the sewing on the ends of the straps so that the firm can be sure that the returned straps are not the new replacement straps. For questions or additional information, contact Rifton Equipment at 1-800-571-8198.
• Quantity in Commerce: Potentially 147 units may be affected.
• Distribution: Worldwide Distribution including USA and countries of Spain and Great Britain.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.