Recall Z-0049-2020 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
| Date | May 2, 2019 |
| Status | Terminated |
| Reason | After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population. |
| Root cause | Under Investigation by firm |
| Action | BD MDS (Medication Delivery Solutions) initiated communication to US on May 2, 2019 via Fed'X. Letter states product defect, health risk and action to take:1. Immediately review for the specific Catalogue (Ref) and lot numbers . Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted m |
| Quantity | 115,200 |
| Distribution | Nationwide Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083472 | MEDEGEN PRESSURE RATED EXTENSION SETS Medegen, Inc., Dec 9, 2008 |