Recall Z-0161-2022 ยท IKZ Bed, Patient Rotation, Powered
Kinsman Enterprises Inc
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
| Date | Sep 10, 2021 |
| Status | Terminated |
| Reason | The belt may fail at lower loads than the labeled 600lbs. |
| Root cause | Component change control |
| Action | The recalling firm sent recall notification via email beginning 09/23/2021. The scope of the recall includes all product (Items 80805, 80806, and 80807) shipped between May 17, 2021 and August 11, 2021. Customers are asked to immediately check stock and quarantine any impacted product. Impacted product is not to be used. Recalled devices must be returned to the recalling firm and will be replaced. A Verification Form should be completed and returned via email to recall@kinsmanenterprises.com. Distributors must promptly notify any potentially impacted customers to which they have further |
| Quantity | 13,123 units |
| Distribution | Distribution in CA, FL, GA, IL, KY, MI, MS, NC, NH, NJ, NY, OH, TN, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.