Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2217-2017Class II

Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000

Cardinal Scale Mfg Co / initiated 2015-12-23 / Terminated / root cause: design

Cardinal Scale Mfg Co began a recall of Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000 on . FDA classified it as Class II and gives the reason as "One complaint of a seat on a scale failing unexpectedly which can cause an injury". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2217-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cardinal Scale Mfg Co
Product
Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
Product code
FRI Scale, Stand-On, Patient
Reason for recall
One complaint of a seat on a scale failing unexpectedly which can cause an injury.
Root cause tag
design
FDA root cause
Device Design
Action
On 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 commerce
975 scales
Distribution
Worldwide 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,
Product codes and lots
None.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2217-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2217-2017Class IITerminatedVoluntary: Firm initiated