Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0

FDA device recall Z-0975-2009 · posted 2009-02-09 · Terminated

Recall details

Recalling firm

Medtronic Inc

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

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

DTZ

Quantity affected

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, P

Date initiated

2008-10-17

Date posted

2009-02-09

Date terminated

2011-04-19

Location

Minneapolis, MN