Z-1853-2017Class II

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

Name: Z-1853-2017 NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2017-01-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-01-13 / Terminated / root cause: packaging

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 on 2017-01-13. FDA classified it as Class II and gives the reason as "The product has the potential to be non-sterile as it was not packaged in accordance to specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1853-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-13
Posted: 2017-03-29
Terminated: 2018-06-25
Recalling firm: Boston Scientific Corporation
Product: NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Product code: FPA Set, Administration, Intravascular
Reason for recall: The product has the potential to be non-sterile as it was not packaged in accordance to specification.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 8 boxes/25 units
Distribution: CA, KY, MD, OR, VA, TX
Product codes and lots: Lot Number: 5122528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1853-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1853-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18

Product code FPA

K852140Class IINamic Contrast & Fluid Delivery Spikes(various)North American Instrument Corp. / cleared 1985-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)