| Class 2 Device Recall Terumo APS 1 | |
Date Initiated by Firm | October 16, 2006 |
Date Posted | February 14, 2007 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number | Z-0437-2007 |
Recall Event ID |
36492 |
510(K)Number | K022947 |
Product Classification |
Perfusion System - Product Code DTQ
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Product | Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041. |
Code Information |
Serial numbers 0030, 0033, 0034, 0036, 0037, 0038, 0041, 0042, 0043, 0045, 0046, 0047, 0048, 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165, 0166, 0167, 0168, 0169, 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
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For Additional Information Contact | 800-521-2818 |
Manufacturer Reason for Recall | The large roller pump may experience false "overspeed' error message when starting rotation, which will prevent the pump from operating; until the condition is cleared by power cycling the roller pump. |
FDA Determined Cause 2 | Other |
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 units |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DTQ
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