Recalls / —

—#181838

Product

Extra corporeal circuit with bio-active surface.

FDA product code

DTZ — Oxygenator, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K891687

Affected lot / code info

Lot# 215729283

Why it was recalled

Affected products failed a sterilization test.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On August 8th Medtronic vervally communicated to the consignees to informed them about the situation and affected product. On August 20th they send a letter to the consignees stating that "as a result of the immediate verbal communication, your Medtronic representative has already retrieved the affected product from your facility. This notification is for your awareness and Medtronic requests that you complete and return the attached Customer Confirmation Certificate to RS.CFQFCA@Medtronic.com."

Recalling firm

Firm

Medtronic Perfusion Systems

Address

7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern

Domestic Distribution only to CA and MI.

Timeline

Recall initiated

2018-08-08

Terminated

2020-10-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.