Device recall

Z-1248-2017: SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED…

FDA device recall · Class III · DeRoyal Industries Inc

Key facts

Recall number (Z-number) Z-1248-2017
Recall event 76359
Product SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Product code LRO
Recalling firm DeRoyal Industries Inc
Recall class Class III
Status Terminated
Termination date Jan 13, 2022
FEI number 1043214

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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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