Device recall

Z-1697-2012: Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336…

FDA device recall · Class II · Covidien LLC

Key facts

Recall number (Z-number) Z-1697-2012
Recall event 61908
Product Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin
Product code FMF
Recalling firm Covidien LLC
Recall class Class II
Status Terminated
Termination date Jun 10, 2013
510(k) numbers K922522
FEI number 1282497

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

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