Becker and Exacta External Drainage and Monitoring Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Exacta With Edm Ventricular Catheter Kit (Barium) |
More than 10 numbers, contact manufacturer. |
27581 |
Becker External Drainage And Monitoring System With Blue Core Needleless Injection Site And Bonded Patient Line Connections |
More than 10 numbers, contact manufacturer. |
27779 |
Becker External Drainage And Monitoring System |
More than 10 numbers, contact manufacturer. |
46128 |
Exacta External Drainage And Monitoring System With Blue Core Needleless Injection Sites |
More than 10 numbers, contact manufacturer. |
27785 |
Exacta Drainage System, 100ml, With Luer Lock |
More than 10 numbers, contact manufacturer. |
46705 |
Exacta External Drainage And Monitoring System |
More than 10 numbers, contact manufacturer. |
46700 |
Issue
Medtronic has received customer complaints reporting cracks and/or leaks on the stopcock of Becker and Exacta EDMS devices. On these devices, the stopcocks may be in three different locations in the EDMS, depending on the specific system configuration. Cracks or leaks of the stopcock can compromise line integrity and, as a result, present a potential for infection. Three adverse events associated with patient infection have been reported.
Recall start date: November 1, 2024
Additional information
Details
| Medtronic Inc. |
| 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432 |
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