Device recall

Z-2420-2011: Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only…

FDA device recall · Class II · Haemonetics Corporation

Key facts

Recall number (Z-number) Z-2420-2011
Recall event 58658
Product Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. Provides perioperative autotransfusion (…
Product code CAC
Recalling firm Haemonetics Corporation
Recall class Class II
Status Terminated
Termination date Apr 21, 2014
510(k) numbers K992723
FEI number 1219343

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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