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Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The… recallZ-0340-2007 · Medtronic Perfusion Systems · initiated Sep 13, 2006

Terminated All recalls posted in January 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0340-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 13, 2006
Posted by the FDA
Jan 25, 2007
Recalling firm
Medtronic Perfusion Systems
Quantity
146
Product code
DWE
FDA submissions
K800178
Distribution
Distributed in 6 states: CA, FL, IL, IN, LA and TN

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

113 devices cleared under K800178 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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