Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2614-2017Class II

Standex International Bakers Pride Microwave Ovens Model E300

Standex Intl Corp / initiated 2017-01-01 / Terminated / root cause: design

Standex Intl Corp began a recall of Standex International Bakers Pride Microwave Ovens Model E300 on . FDA classified it as Class II and gives the reason as "It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2614-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Standex Intl Corp
Product
Standex International Bakers Pride Microwave Ovens Model E300
Product code
RCR Microwave Oven, Consumer
Reason for recall
It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
Root cause tag
design
FDA root cause
Device Design
Action
The Standex Cooking Solutions Group plans to replace all 149 Bakers Pride Model E300 Speed Ovens remaining in the field as follows : 1.Product design changes include (a) an updated interlock switch mounting that reduces the effects of shipping and handling on switch positioning; (b) a revised mechanism for the secondary interlock switch to prevent operation by any part of the human body or any object with a straight insertable length of 3.9 inches. A 200,000-cycle leakage measurement is conducted and will be finished by July 31, 2017. 2.The updated replacement oven will be shipped with the improved, stronger bracing materials and added cover over the handle with markings and changes in the door mechanism. 3.New compliant ovens will be delivered by an installer to distributors and owners. 4.All shipping and installation costs for delivery of the new units and return of the old units will be paid by Standex International Corporation. 5.The updated and corrected pages of the Service Manual and Owners Manual will be included with the delivery of the replacement oven, and the corrected warning label and Certification label will be permanently affixed to the replacement ovens. 6.Standex International Corporation expects to deliver the replacement units after testing, which will be completed by July 31, 2017. Distributors and customers will then be given a period of 4 weeks to return the old unit. 7.All returned ovens will be updated to revised construction and subjected to the full Unit Test Procedure required for new products. Ovens that cannot be updated will be destroyed. 8.Progress reports will be provided to FDA on the 15th of every month until all non-compliant ovens have been replaced with new compliant ovens, returned to the factory and modified to the revised and compliant construction, as verified by conducting the Unit Test Procedure. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and
Quantity in commerce
149
Distribution
US Distribution
Product codes and lots
S/N: 562071609002 562071706001 562071608015 562071609003 562071608014 562071609001

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2614-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2614-2017Class IITerminatedFDA Mandated