Z-0975-2009

Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood...

Name: Z-0975-2009 Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood...
Creator: Medtronic Inc
Published: 2008-10-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-10-17 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc began a recall of Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene... on 2008-10-17. The reason FDA records is "Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect "Recommended...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0975-2009
Status: Terminated
Initiated: 2008-10-17
Posted: 2009-02-09
Terminated: 2011-04-19
Recalling firm: Medtronic, Inc.
Product: Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacturer: Medtronic Inc., Minneapolis, MN 55432-5604. Surgical Membrane Oxygenators are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures. Additionally, the Integral Membrane Oxygenators are intended to cool and warm the blood by means of the integral heat exchange.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect "Recommended maximum blood flow range" on the label. The label on the device states a range of 5.0 - 8.5 L/min but should state a range of 5.0 - 6.5 L/min. These oxygenators are acceptable t
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A consignee letter " Urgent Medical Deive Notice" dated October 17, 2008 was sent to the impacted customers on October 17, 2008. The letter described the issue and product and confirmed the correct maximum internal flow of 6.5 L/min for the I-4500 Silicone Oxygenators. The letter states the product will not be removed from the field. Customers were instructed to complete the" Medtronic Product Notification Certificate (FCA 0903)" acknowledging receipt of the information and fax the completed certificate to 763-391-9603. Please direct questions about the recall to your Medtronic Sales Representative or call 763-391-9124.
Quantity in commerce: 408
Distribution: Worldwide Distribution USA including states of CA, CO, FL, IL, IN, KY, LA, MD, MI, MN, MO, NV, NJ, NY, OH, OK PA, TN, TX, UT, VA, and WI, and countries of LATVIA, ITALY, ARMENIA, RUSSIAN FEDERATION, POLAND, CHILE and CHINA.
Product codes and lots: Lot Numbers: 10058759, 9984675, 9956368, 9916066, 989741, 9875810, 9866275, 9854094, 9828585, 9812351, 9421573, 9169873, 9044915, 8956269, 8938159, 8885755 and 8765243. Serial Numbers: IH31608 - IH32031.

Product code DTZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)