Device recall

Z-1124-2018: 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266…

FDA device recall · Class II · Medical Components, Inc dba MedComp

Key facts

Recall number (Z-number) Z-1124-2018
Recall event 79436
Product 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Product code NFK
Recalling firm Medical Components, Inc dba MedComp
Recall class Class II
Status Terminated
Termination date Jan 10, 2020
510(k) numbers K022570
FEI number 2518902

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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