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U.S. Department of Health and Human Services

Class 2 Device Recall Rules Based Medicine blood collection kit

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 Class 2 Device Recall Rules Based Medicine blood collection kitsee related information
Date Initiated by FirmJanuary 09, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on December 26, 2012
Recall NumberZ-0534-2012
Recall Event ID 57863
Product Classification Container, specimen mailer and storage, sterile - Product Code KDT
ProductRules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. 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 ContactVicki Harbarger
913-764-1045
Manufacturer Reason
for Recall		Kits contain recalled Triad alcohol pads
FDA Determined
Cause 2		Material/Component Contamination
ActionHeritage 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 Commerce900 kits
DistributionWorldwide Distribution - USA (nationwide) and Germany
Total Product Life CycleTPLC 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.
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