FDA recall Z-2951-2018

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 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.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-07-13

Report date

2018-09-05

Termination date

2020-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Braintree, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2951-2018