Recall Z-0236-2007 ยท DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
| Date | Dec 7, 2006 (initiated Sep 14, 2006) |
| Status | Terminated |
| Reason | The hand crank handle may separate and detach from the unit during use. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06. |
| Quantity | 124 |
| Distribution | Worldwide Distribution, USA and 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM 3M Health Care, Sarns, Jul 8, 1992 |