Device recall

Z-2285-2021: Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code…

FDA device recall · Class I · Cardinal Health

Key facts

Recall number (Z-number) Z-2285-2021
Recall event 88421
Product Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Product code NGT
Recalling firm Cardinal Health
Recall class Class I
Status Open, Classified
510(k) numbers K032438
FEI number 3014524790

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)