Recall Z-1853-2017— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-1853-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2017-01-13, terminated 2018-06-25. It names one FDA 510(k) clearance: K852140. Product: NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005. Reason: The product has the potential to be non-sterile as it was not packaged in accordance to specification..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2017-01-13
Terminated: 2018-06-25
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K852140 — NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)North American Instrument Corp.·cleared 1985-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.