Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicat
FDA device recall Z-0303-2012 · posted 2011-11-29 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.
- Action taken
- Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DWB
- Quantity affected
- 10 units
- Distribution
- Nationwide Distribution (USA) including the state of San Antonio, TX
- Date initiated
- 2011-10-21
- Date posted
- 2011-11-29
- Date terminated
- 2012-02-17
- 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 |