—#74883

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.

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot Numbers: 10058759, 9984675, 9956368, 9916066, 989741, 9875810, 9866275, 9854094, 9828585, 9812351, 9421573, 9169873, 9044915, 8956269, 8938159, 8885755 and 8765243. Serial Numbers: IH31608 - IH32031.

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-10-17
Posted by FDA: 2009-02-09
Terminated: 2011-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.