Z-0161-2022Class II
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Kinsman Enterprises Inc / initiated 2021-09-10 / Terminated / root cause: labeling and UDI
Kinsman Enterprises Inc began a recall of Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) on . FDA classified it as Class II and gives the reason as "The belt may fail at lower loads than the labeled 600lbs". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0161-2022
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Kinsman Enterprises Inc
- Product
- Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
- Product code
- IKZ Bed, Patient Rotation, Powered
- Reason for recall
- The belt may fail at lower loads than the labeled 600lbs.
- Root cause tag
- labeling and UDI
- FDA 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 [email protected]. Distributors must promptly notify any potentially impacted customers to which they have further distributed product.
- Quantity in commerce
- 13,123 units
- Distribution
- Distribution in CA, FL, GA, IL, KY, MI, MS, NC, NH, NJ, NY, OH, TN, VA
- Product codes and lots
- Kinsman Product Numbers: 80805 (54"), 80806 (60"), and 80807 (72") UPC codes: 873704007275, 873704006773, 873704007282
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0161-2022 | Class II | Terminated | Voluntary: Firm initiated |
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