NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005

FDA device recall Z-1853-2017 · posted 2017-03-29 · Terminated

Recall details

Recalling firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Reason for recall

The product has the potential to be non-sterile as it was not packaged in accordance to specification.

Action taken

On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FPA

Quantity affected

8 boxes/25 units

Distribution

CA, KY, MD, OR, VA, TX

Date initiated

2017-01-13

Date posted

2017-03-29

Date terminated

2018-06-25

Location

Glens Falls, NY

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