—#49877

Product

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 product code: DWE — Tubing, Pump, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K800178, K891687
Affected lot / code info: Lot 5666215

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Illinois

Timeline

Recall initiated: 2007-01-02
Posted by FDA: 2007-03-08
Terminated: 2008-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49877. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.