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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal, Digital Bariatric Scale

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 Class 2 Device Recall Cardinal, Digital Bariatric Scalesee related information
Date Initiated by FirmDecember 23, 2015
Date PostedJune 01, 2017
Recall Status1 Terminated 3 on June 28, 2017
Recall NumberZ-2217-2017
Recall Event ID 76975
Product Classification Scale, stand-on, patient - Product Code FRI
ProductCardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
Code Information None.
FEI Number 1929045
Recalling Firm/
Manufacturer		 Cardinal Scale Mfg Co
203 E Daugherty St
Webb City MO 64870-1929
For Additional Information ContactMark Levels
417-673-4631
Manufacturer Reason
for Recall		One complaint of a seat on a scale failing unexpectedly which can cause an injury.
FDA Determined
Cause 2		Device Design
ActionOn 12/23/2015, the recalling firm sent a letter to their customers. The letter accompanied a kit to be installed immediately upon receipt. For assistance with installation contact technical service department at 866-254-8261.
Quantity in Commerce975 scales
DistributionWorldwide distribution - US Nationwide in the states: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, NEW JERSEY, New York, NORTH CAROLINA, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Product was also distributed to the following foreign countries: Canada, Hong Kong, Kuwait, Pakistan,
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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