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Terminated

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

FDA Recall Z-1110-2007 · Posted 2007-07-26

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDTZ
Date Initiated2007-04-18
Date Terminated2007-11-01
Product Quantity11 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide: Distributed to states of CO and PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K926226INTERSEPT FILTERED CARDIOTOMY RESERVOIRMedtronic Vascular · 1993-06-22

Official Source

View FDA Recall →

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

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