Recall Z-2951-2018— Haemonetics Corporation

Name: FDA recall Z-2951-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-13

Class II · Terminated

Class II FDA medical device recall by Haemonetics Corporation, initiated 2018-07-13, terminated 2020-06-16. It names one FDA 510(k) clearance: K122262. 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. Reason: 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..

Recalling firm: Haemonetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Terminated: 2020-06-16
Firm location: Braintree, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122262 — ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMHaemonetics Corp.·cleared 2012-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.