Device recall

Z-0065-2011: Control Syringe, 10ml, CAT No: CCX011 Version A, Sterile R, Merit Medical…

FDA device recall · Class II · Merit Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-0065-2011
Recall event 56756
Product Control Syringe, 10ml, CAT No: CCX011 Version A, Sterile R, Merit Medical Systems, Inc. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes.
Product code FMF
Recalling firm Merit Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Mar 21, 2011
510(k) numbers K875196
FEI number 1721504

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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