Medical Device
Manufacturing
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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
FDA enforcement reports joined to recall event Z-0161-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0161-2022Class IITerminatedVoluntary: Firm initiated