Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
This recall has been terminated (originally issued December 27, 2006).
- Recall Initiated
- November 10, 2006
- Posted
- December 27, 2006
- Terminated
- June 19, 2008
- Recall Number
- Z-0306-2007
- Quantity
- 488
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
Distribution
Worldwide, including USA, 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.
Lot / Code Info
All units. Serial numbers 0011 through 0499.
Root Cause
Other
Action Taken
A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.