FDA recall Z-1390-2018

Product

Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.

Reason for recall

NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.

Distribution

Recall conducted to end user level. Recall Notifications were delivered by Fed Express.

Key facts

Status

Terminated

Initiation date

2018-01-18

Report date

2018-04-25

Termination date

2018-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glens Falls, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2018