FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: 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.
- Recall number
- Z-1336-2012
- Recalling firm
- bioMerieux, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-03-05
- Posted
- 2012-03-30
- Terminated
- 2014-09-04
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Catalog Number: 279012, 210361 and 410796
- 510(k) numbers
- ["K933939"]
- PMA numbers
- not on file
- Product code
- GIM
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28