Device recall

Z-0565-2011: MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml…

FDA device recall · Class II · Covidien LP

Key facts

Recall number (Z-number) Z-0565-2011
Recall event 57315
Product MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123
Product code NGT
Recalling firm Covidien LP
Recall class Class II
Status Terminated
Termination date Dec 4, 2015
510(k) numbers K032438
FEI number 1282497

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)