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U.S. Department of Health and Human Services

Class 3 Device Recall Healthwear

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  Class 3 Device Recall Healthwear see related information
Date Initiated by Firm May 03, 2005
Date Posted August 12, 2005
Recall Status1 Terminated 3 on October 05, 2005
Recall Number Z-1113-05
Recall Event ID 31836
Product Classification unknown device name - Product Code LYW
Product Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Customer Service
800-546-6130
Manufacturer Reason
for Recall		 Lack of adequate manufacturing controls.
FDA Determined
Cause 2		 Other
Action Consignees were notified via letter dated 5/3/05. Customers were requested to discard their device and to respond to Roche for a refund. The firm''s internet support site for the system is being turned off.
Quantity in Commerce 1,005
Distribution Nationwide.
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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