—#48433

Product

Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine. Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Tube supplier: Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA 91748.

FDA product code: DWE — Tubing, Pump, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K800178
Affected lot / code info: The following Model / Lot Number are affected: CB4W39R1 / 4876667; 0A84R2 / 4531036; 1708R18 / 4627100; 0V68R4 / 4212182; 1P07R6 / 4433014; 1P07R6 / 4678134; 2Y91R / 4628170; 2Y91R / 4800224; 2Y91R / 4902036; CB0Q49R14 / 4800849; 4D87R2 / 4184927.

Why it was recalled

An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.

Root cause (FDA determination)

Other

Action the firm took

An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.

Recalling firm

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

Distribution

Distribution pattern: Distributed in 6 states: CA, FL, IL, IN, LA and TN

Timeline

Recall initiated: 2006-09-13
Posted by FDA: 2007-01-25
Terminated: 2007-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.