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U.S. Department of Health and Human Services

Class 2 Device Recall Bakers Pride Model E300 Speed Ovens

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  Class 2 Device Recall Bakers Pride Model E300 Speed Ovens see related information
Date Initiated by Firm January 01, 2017
Create Date July 14, 2017
Recall Status1 Open3, Classified
Recall Number Z-2614-2017
Recall Event ID 77581
Product Classification Microwave oven, consumer - Product Code RCR
Product Standex International Bakers Pride Microwave Ovens Model E300
Code Information S/N:, 562071609002, 562071706001, 562071608015, 562071609003, 562071608014, 562071609001
Recalling Firm/
Manufacturer
Standex Intl Corp
11 Keewaydin Dr
Salem NH 03079-2999
For Additional Information Contact
603-893-9701
Manufacturer Reason
for Recall
It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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