Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110.
This recall has been terminated (originally issued December 30, 2006).
- Recall Initiated
- October 12, 2004
- Posted
- December 30, 2006
- Terminated
- February 1, 2007
- Recall Number
- Z-0326-2007
- Quantity
- 4,740 for all affected products
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
Distribution
Worldwide Distribution-USA and countries 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
Serial numbers 00023 through 00026, 00034, 00041, 00051, 00060, 00063 through 00065, 00067 through 00069, 00071 through 00089, 00091 through 00139, 00141 through 00242, 00246 through 00280, 00282 through 00297, 00299 through 00323, 00325 through 00410 and 00419.
Root Cause
Other
Action Taken
U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.