NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
FDA Recall Z-1853-2017 · Posted 2017-03-29
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Recalling FirmAngiodynamics Inc. (Navilyst Medical Inc.)
Recall StatusTerminated
Product CodeFPA
Date Initiated2017-01-13
Date Terminated2018-06-25
Product Quantity8 boxes/25 units
Reason for Recall
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
Firm Action
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
Distribution Pattern
CA, KY, MD, OR, VA, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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