The Recall Desk

FDA (Devices) recall action 80740

Haemonetics Corporation recalled 2 products on 2018-09-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-09-05
Critical
0
Units
780

Why these products were recalled

OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2018-09-05

    Haemonetics OrthoPAT Reservoirs Recalled Due to Missing Cannula

    Haemonetics is recalling 348 OrthoPAT QuickConnect Reservoirs because a missing cannula prevents blood from being emptied and processed.

    Product
    Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-09-05

    Haemonetics OrthoPAT System-Integrated Set Recalled Due to Missing Cannula

    Haemonetics is recalling OrthoPAT System-Integrated Sets because missing cannulas prevent blood from emptying, making the collected blood unusable.

    Product
    Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
    Category
    Distribution
    0 states