Recall Z-0931-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
| Date | Jun 30, 2007 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing. |
| Root cause | Other |
| Action | The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur. |
| Quantity | 1982 total for both models |
| Distribution | Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp., Mar 20, 2003 |