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U.S. Department of Health and Human Services

Class 2 Device Recall EasiCare Gait Belt

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 Class 2 Device Recall EasiCare Gait Beltsee related information
Date Initiated by FirmSeptember 10, 2021
Create DateOctober 21, 2021
Recall Status1 Terminated 3 on August 27, 2025
Recall NumberZ-0161-2022
Recall Event ID 88760
Product Classification Bed, patient rotation, powered - Product Code IKZ
ProductEasi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Code Information Kinsman Product Numbers: 80805 (54"), 80806 (60"), and 80807 (72") UPC codes: 873704007275, 873704006773, 873704007282
FEI Number 1000570634
Recalling Firm/
Manufacturer		 Kinsman Enterprises Inc
10804 Mark Twain Rd
W Frankfort IL 62896-4105
For Additional Information Contact
618-932-3838
Manufacturer Reason
for Recall		The belt may fail at lower loads than the labeled 600lbs.
FDA Determined
Cause 2		Component change control
ActionThe 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 distributed product.
Quantity in Commerce13,123 units
DistributionDistribution in CA, FL, GA, IL, KY, MI, MS, NC, NH, NJ, NY, OH, TN, VA
Total Product Life CycleTPLC 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.
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