AllClear
PricingSign in
FDAJanuary 8, 2024device

BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.

What to do

FDA enforcement status: Ongoing

Brands named

maquet medical systemsmaquetmaquet medical

UPCs

4037691650326

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. — Recall Details · AllClear