Recall Z-2707-2011 ยท FPA Set, Administration, Intravascular
Carefusion 303, Inc.
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
| Date | Jun 29, 2011 (initiated Apr 20, 2011) |
| Status | Terminated |
| Reason | Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component. |
| Root cause | Device Design |
| Action | CareFusion initiated on May 3, 2011, two distinctive "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via mail delivery, to all affected customers and distributors. The notices identified the product, the problem, and the actions to be taken. Customers were instructed to 1.) Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card to CareFusion. Note on the card your distributor, the MaxPlus bifuse extension set lot numbers and quantities that will be returned. 2.) All recalled product should be returned directly to the distributor from whom it was purchased |
| Quantity | 26,150 units |
| Distribution | Nationwide Distribution -- USA including states of: CA, IA, IN, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET Medegen Medical Manufacturing Services, Jun 22, 2005 |