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Terminated

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

FDA Recall Z-1390-2018 · Posted None

Recalling FirmAngiodynamics Inc. (Navilyst Medical Inc.)
Recall StatusTerminated
Product CodeOEQ
Date Initiated2018-01-18
Date Terminated2018-09-21
Product Quantity38 units

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.

Firm Action

Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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