Recall Z-1336-2012 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
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.
| Date | Mar 30, 2012 (initiated Mar 5, 2012) |
| Status | Terminated |
| 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 cus |
| 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, Switzerlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933939 | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT Organon Teknika Corp., Feb 7, 1994 |