Device recall

Z-1356-04: Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire…

FDA device recall · Class II · Terumo Cardiovascular Systems Corp

Key facts

Recall number (Z-number) Z-1356-04
Recall event 29475
Product Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet, smooth balloon; catalog number 7270.
Product code DWF
Recalling firm Terumo Cardiovascular Systems Corp
Recall class Class II
Status Terminated
Termination date Oct 26, 2004
510(k) numbers K915193
FEI number 1828100

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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