Medtronic Inc 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 i Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

CA, CO, FL, IL, IN, KY, LA, MD, MI, MN, MO, NV, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WI