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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT Blood Collection Adapter

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  Class 2 Device Recall BacT/ALERT Blood Collection Adapter see related information
Date Initiated by Firm March 05, 2012
Date Posted March 30, 2012
Recall Status1 Terminated 3 on September 04, 2014
Recall Number Z-1336-2012
Recall Event ID 61362
510(K)Number K933939  
Product Classification Tubes, vacuum sample, with anticoagulant - Product Code GIM
Product BacT/ALERT Blood Collection Adapter

The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set.
Code Information Catalog Number: 279012, 210361 and 410796
Recalling Firm/
Manufacturer
bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Benjamin Smith
314-731-8537
Manufacturer Reason
for Recall
The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.
FDA Determined
Cause 2
Nonconforming Material/Component
Action bioMerieux sent an Urgent Product Correction Notice letter dated March 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Ensure the letter and guidance on how to maintain control of the luer connector by securing it between the thumb and forefinger are distributed to all appropriate personnel within their organization. 2. Fill out and return the Acknowledgement Form by Fax to confirm receipt of the recall notice. For additional assistance or questions customers were instructed to contact their local bioMerieux Customer Service Representative at (800) 682-2666, option 3, then option 3 again. Industry customers should call 800- 634-7656, option 3. For questions regarding this recall call 314-731-8537.
Quantity in Commerce 274,800 boxes (32,862,600 caps)
Distribution Worldwide Distribution - USA (nationwide), Australia, Brazil, Canada, Chile, Columbia, Costa Rica, France, China, Indonesia, Korea, Mexico, Peru, Singapore, Ecuador, Dominican Republic, Philippines, Guatemala, Curacao, Thailand, United Arab Emirates, Andorra, Austria, Burkina Faso, Congo, Switzerland, Cameroon, Germany, Algeria, Estonia, Spain, France, Great Britain, French Guiana, Croatia, Israel, India, Italy, Kazakhstan, Lithuania, Latvia, Macedonia, Malta, New Caledonia, Netherlands, French Polynesia, Poland, Portugal, Reunion, Russia, Sweden, Slovenia, Chad, Turkey, South Africa, Saudi Arabia, Congo, Cote DIvoire, Denmark, Djibouti, Finland, Greece, Guadeloupe, Libyan Arab Jamahiriya, Jordan, Morocco, Martinique, Norway, Senegal, Togo, Yemen, Bangladesh, Georgia, Ghana, Uganda, and Qatar.
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 = GIM and Original Applicant = ORGANON TEKNIKA CORP.
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