Z-0049-2020 Class II Terminated
FDA device recall Z-0049-2020 was initiated by Becton Dickinson & Company on May 2, 2019 and is designated Class II. Reason for recall: 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 p… The recall status is terminated (terminated November 30, 2021). Affected quantity: 115,200.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- November 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115,200
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide Foreign: Canada
Code Information
Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228