Device recall

Z-1072-2019: ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood…

FDA device recall · Class II · ICU Medical, Inc.

Key facts

Recall number (Z-number) Z-1072-2019
Recall event 81743
Product ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
Product code DRS
Recalling firm ICU Medical, Inc.
Recall class Class II
Status Terminated
Termination date Feb 1, 2022
510(k) numbers K831506
FEI number 2025816

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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