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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Terumo Advanced Perfusion System 		see related information
Date Posted February 14, 2007
Recall Number Z-0439-2007
Product Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Code Information Serial numbers 0029, 0031 through 0043, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0068, 0070 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0111, 0113 through 0117, 0120 through 0123, 0125 through 0180, 0182 through 0191, 0194, 0195, 0197-0207, 0209, 0211 through 0527, 0700 through 0725, 0727, 0730 through 0878, 0880, 0881, 0883 through 0977, 0981 through 0990, 0992, 0993, 0995 through 1266, 1268 through 1528, 1539 through 1579, 2000 through 2018, 2023, 2025, 2027 through 2057 and 2072 through 2083.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Reason for
Recall		 The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.
Action Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
Quantity in Commerce 1,951
Distribution Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
 
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