Recall Z-0305-2011 ยท LHI Set, I.V. Fluid Transfer
B. Braun Medical Inc
B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
| Date | Nov 5, 2010 (initiated Jun 24, 2010) |
| Status | Terminated |
| Reason | During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution. |
| Root cause | Device Design |
| Action | On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached "Product Removal Acknowledgement" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at |
| Quantity | 33,905,600 units |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090905 | ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE B.Braun Medical, Inc., Apr 27, 2009 |