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U.S. Department of Health and Human Services

Class 2 Device Recall OralEze (R) Oral Fluid Collection System

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  Class 2 Device Recall OralEze (R) Oral Fluid Collection System see related information
Date Initiated by Firm October 07, 2011
Date Posted February 24, 2012
Recall Status1 Terminated 3 on August 24, 2012
Recall Number Z-1101-2012
Recall Event ID 60981
510(K)Number K984361  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832

Product Usage:
IVD for drugs of abuse
Code Information Lot #, Expiration date:  07192011, exp. 04-30-2013; 07202011, exp. 04-31-2013; 07212011, exp. 04-31-2013; 07222011, exp. 05-31-2013; 07252011, exp. 05-31-2013; 07262011, exp. 05-31-2013; 07272011, exp. 05-31-2013; 07282011, exp. 05-31-2013; 07292011, exp. 05-31-2013; 07302011, exp. 05-31-2013; 07312011, exp. 05-31-2013; 08012011, exp. 05-31-2013;  08022011, exp. 05-31-2013; 08032011, exp. 05-31-2013; 08042011, exp. 05-31-2013; 08052011, exp. 05-31-2013; 08062011, exp. 05-31-2013; 08072011, exp. 05-31-2013; 08082011, exp. 05-31-2013; 08092011, exp. 05-31-2013; 08102011, exp. 05-31-2013; 08112011, exp. 05-31-2013; 08122011, exp. 05-31-2013; 08132011, exp. 05-31-2013;  08142011, exp. 05-31-2013; 08152011, exp. 05-31-2013; 08162011, exp. 05-31-2013; 08172011, exp. 05-31-2013; 08182011, exp. 05-31-2013; 08192011, exp. 05-31-2013; 08212011, exp. 05-31-2013; 08222011, exp. 05-31-2013; 08232011, exp. 05-31-2013; 08242011, exp. 05-31-2013
Recalling Firm/
Manufacturer
Capitol Vial Inc
2039 Mcmillan St
Auburn AL 36832-4271
For Additional Information Contact Leah M. Garza
334-887-8311
Manufacturer Reason
for Recall
Low buffer fill volumes on Oral-Eze, an oral fluid collection system.
FDA Determined
Cause 2
Device Design
Action Thermo-Fisher Scientific/Capital Vial sent a Recall Notification letter dated October 7, 2011 to the sole consignee. The letter identified the affected product, problem, result impact and necessary actions to be taken. The consignee was instructed to discontinue use of the affected product and follow the necessary actions provided. If you have any questions regarding this information, call Michael Hect, Manufacturing Manager through Customer Service at (800) 772-8871.
Quantity in Commerce 135,000 units
Distribution (USA) Nationwide Distribution - in the state of KS
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 = JKA and Original Applicant = OSBORN LABORATORIES, INC.
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