Device recall

Z-1219-2014: Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector…

FDA device recall · Class II · Terumo Cardiovascular Systems Corporation

Key facts

Recall number (Z-number) Z-1219-2014
Recall event 67598
Product Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava…
Product code DWF
Recalling firm Terumo Cardiovascular Systems Corporation
Recall class Class II
Status Terminated
Termination date Aug 12, 2014
510(k) numbers K920902
FEI number 1828100

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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