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U.S. Department of Health and Human Services

Class 2 Device Recall Heritage Labs University of Michigan Clinical Kit

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  Class 2 Device Recall Heritage Labs University of Michigan Clinical Kit see related information
Date Initiated by Firm January 09, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 26, 2012
Recall Number Z-0578-2012
Recall Event ID 57863
510(K)Number K990899  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product Heritage Labs University of Michigan Clinical Kit, Product K8311, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions.

Blood specimen collection
Code Information All kits containing Triad alcohol prep pads
Recalling Firm/
Manufacturer		 Heritage Labs International LLC
560 N Rogers Rd
Olathe KS 66062-1211
For Additional Information Contact Vicki Harbarger
913-764-1045
Manufacturer Reason
for Recall		 Kits contain recalled Triad alcohol pads
FDA Determined
Cause 2		 Material/Component Contamination
Action Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.
Quantity in Commerce 18 kits
Distribution Worldwide Distribution - USA (nationwide) and Germany
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = OSBORN GROUP, INC.
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