System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the ex
FDA device recall Z-2218-2012 · posted 2012-08-16 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
- Action taken
- Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 3
- Distribution
- US Nationwide Distribution - including the state of New York
- Date initiated
- 2012-06-20
- Date posted
- 2012-08-16
- Date terminated
- 2012-11-07
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS 8000 MODULAR PERFUSION SYSTEM (K915183) | 3M Health Care, Sarns | 1992-07-08 |