—#50236

Product

Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K926226
Affected lot / code info: Lot 7192800

Why it was recalled

Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic.

Root cause (FDA determination)

Other

Action the firm took

The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information.

Recalling firm

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

Distribution

Distribution pattern: Nationwide: Distributed to states of CO and PA

Timeline

Recall initiated: 2007-04-18
Posted by FDA: 2007-07-26
Terminated: 2007-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.