Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx recall — FDA Z-1892-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Overview of recall records associated with Medtronic Perfusion Systems, including dates, categories and classifications where available.
Classification mix: Class II: 72, Class I: 12.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the…
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
This page summarizes recall records in which the official source identifies Medtronic Perfusion Systems as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.