Date Initiated by Firm | January 09, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on December 26, 2012 |
Recall Number | Z-0528-2012 |
Recall Event ID |
57863 |
510(K)Number | K990899 |
Product Classification |
Assay, glycosylated hemoglobin - Product Code LCP
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Product | Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit 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
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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 | 19,250 kits |
Distribution | Worldwide Distribution - USA (nationwide) and Germany |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = LCP
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