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Terminated

Extra corporeal circuit with bio-active surface.

FDA Recall Z-2495-2020 · Posted None

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDTZ
Date Initiated2018-08-08
Date Terminated2020-10-06
Product Quantity10 units

Reason for Recall

Affected products failed a sterilization test.

Firm Action

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 [email protected]."

Root Cause

Nonconforming Material/Component

Distribution Pattern

Domestic Distribution only to CA and MI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc. · 1989-05-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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