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Terminated

Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.

FDA Recall Z-0583-2007 · Posted 2007-03-08

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWE
Date Initiated2007-01-02
Date Terminated2008-02-24
Product Quantity17

Reason for Recall

One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.

Firm Action

There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.

Root Cause

Other

Distribution Pattern

Illinois

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc. · 1989-05-31K800178EXTRACORP.'S INTERSEPT CUS. TUBING PK.Extracorporeal Medical Specialities, Inc. · 1980-02-21

Official Source

View FDA Recall →

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

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