Device recall

Z-2742-2011: TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit…

FDA device recall · Class II · Haemoscope Division of Haemonetics Corp

Key facts

Recall number (Z-number) Z-2742-2011
Recall event 58847
Product TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
Product code JPA
Recalling firm Haemoscope Division of Haemonetics Corp
Recall class Class II
Status Terminated
Termination date Sep 25, 2012
510(k) numbers K002177
FEI number 2429444

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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