Recall Z-1380-2012 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.
| Date | Apr 6, 2012 (initiated Feb 3, 2012) |
| Status | Terminated |
| Reason | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. |
| Root cause | Labeling design |
| Action | On 2/3/12 all consignees received an URGENT MEDICAL DEVICE RECALL letter via Federal Express. The letter described the reason for the recall, identified the affected product population, what to do in the event of a failure, the potential hazard, and correction. Terumo CVS will update the Operator's Manual for the CDI 500 with instructions to replace the battery within its useful life. Users are to review the notice and ensure that all users are made aware of the issue. In addition, the Customer Response Form should be completed and returned. Users can contact their local Terumo Cardiovasc |
| Quantity | 3,829 units |
| Distribution | Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, WV, WA, and WI and the countries of Japan, Germany, Barbados, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M Company, Nov 6, 1997 |