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Recall

Class II — Angiodynamics Inc. (Navilyst Medical Inc.)

Recalling firmANGIODYNAMICS, INC
Registered facilityView this company's 4 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe product has the potential to be non-sterile as it was not packaged in accordance to specification.
ProductNAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Quantity8 boxes/25 units
DistributionCA, KY, MD, OR, VA, TX
Initiated2017-01-13
Classified2017-04-18
Terminated2018-06-25
Recall numberZ-1853-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Angiodynamics Inc. (Navilyst Medical Inc.) (Z-1853-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76347/

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