Summary
The FDA issued a Class II for Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) by Kinsman Enterprises Inc. Reason: The belt may fail at lower loads than the labeled 600lbs..
Details
Source
Device Recall
External ID
Z-0161-2022
Action Date
2021-10-27
Status
Terminated
Category
device
Product Description
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Lot/Code Info: Kinsman Product Numbers: 80805 (54"), 80806 (60"), and 80807 (72") UPC codes: 873704007275, 873704006773, 873704007282
Quantity Affected: 13,123 units
Reason for Recall
The belt may fail at lower loads than the labeled 600lbs.
Distribution
Distribution in CA, FL, GA, IL, KY, MI, MS, NC, NH, NJ, NY, OH, TN, VA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-10
Company
W Frankfort, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kinsman Enterprises Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kinsman Enterprises Inc have FDA actions?
This is the only FDA action we have on record for Kinsman Enterprises Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0161-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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