Device recall

Z-0583-2007: Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC…

FDA device recall · Class III · Medtronic Perfusion Systems

Key facts

Recall number (Z-number) Z-0583-2007
Recall event 37079
Product Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine…
Product code DWE
Recalling firm Medtronic Perfusion Systems
Recall class Class III
Status Terminated
Termination date Feb 24, 2008
510(k) numbers K800178
FEI number 1000116158

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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